Abbott CDDRA300T Implantable Cardioverter Defibrillators Instruction Manual

: June 8, 2024
: Abbott

Table of Contents

Abbott CDDRA300T Implantable Cardioverter Defibrillators
Product Specifications
Product Usage Instructions
Product Highlights
Ordering Information
Product Specifications
Rx Only
FAQ
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Abbott CDDRA300T Implantable Cardioverter Defibrillators

Product Specifications

Model: CDDRA300T
Telemetry: Delivered/Stored Energy
Volume: 72
Weight: 35
Size: Connector
Defibrillation Lead Connection: DF-1
Atrial Sense/Pace Lead Connection: IS-1
Ventricular Sense/Pace Lead Connection: IS-1
High-Voltage Can Parameter Sensing/Detection: SenseAbilityTM Sensing Algorithm

Product Usage Instructions

Device Setup

Ensure the device is properly implanted according to medical guidelines.
Connect the defibrillation lead to the designated connector.
Connect the atrial and ventricular sense/pace leads to their respective connectors.
Adjust the sensitivity control settings for atrial and ventricular events as needed.

Programming and Configuration

Set the detection zones for different arrhythmias based on patient needs.
Configure SVT discriminators and monitor modes for optimal performance.
Adjust ATP configurations including rates, burst cycle length, and number of stimuli.
Program high-voltage therapy parameters such as pulse width andtilt.

Pacing Modes

Select permanent or temporary pacing modes based on patient requirements.
Adjust activity sensor settings for rate and delay parameters.

Product Highlights

Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption
DeFT Response™ technology offers noninvasive programming options to optimize rescue therapy to each patient’s unique physiology and changing conditions
VF Therapy Assurance decreases time to treatment for arrhythmias in patients who are likely to be hemodynamically unstable
Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock
ShockGuard™ technology with DecisionTx™ programming designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant
- SecureSense™ RV lead noise discrimination algorithm detects sustained lead noise and records short bursts of oversensing that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks
- Far Field MD™ morphology discrimination and chamber onset discrimination enhance SVT and VT discrimination for reduced inappropriate therapies
SenseAbility™ sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
DynamicTx™ over-current detection algorithm automatically changes shock configurations to ensure delivery of high-voltage therapy when high current is detected
MRI Ready device tested in combination with MR Conditional leads for full-body scans using a 1.5T or 3T (Tesla) field strength MRI Scanner*
Cold can programmability provides an additional RV-SVC shock configuration to decouple the can from the shocking vector parameters
Premature Atrial Contraction (PAC) Response to avoid pacing the atrium in a vulnerable zone
Physiologic rate responsive AV Delay and PVARP
Dual patient notification: audio notification through the device and visual notification via myMerlinPulse™ app
The CorVue™ thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient’s heart failure condition

Ordering Information

Contents : Cardiac Pulse Generator

MODEL NUMBER| DIMENSIONS (L × W × H) (MM)| WEIGHT (G)| VOLUME (CC)| CONNECTOR DEFIBRILLATION| CONNECTOR SENSE/PACE
---|---|---|---|---|---
CDDRA300T| 73 × 51 × 12| 72| 35| DF-1| IS-1

Product Specifications

PARAMETER SPECIFICATIONS

Threshold Start

| Post-Sensed: 50; 62.5; 75; 100%

Post-Paced, Atrial: 0.2-3.0 mV

Post-Paced, Ventricular: Auto, 0.2-3.0 mV

__

Decay Delay

| Post-Sensed: 0-220 ms

Post-Paced, Atrial: 0-220 ms

Post-Paced, Ventricular: Auto, 0-220 ms

Ventricular Sense Refractory| 125; 157 ms
Detection Zones| 3 zone programming — 1 zone; 2 zones; or 3 zones (VT-1; VT-2; VF)
__

SVT Discriminators

| AV Rate Branch; Arrhythmia Onset (Chamber Onset or Sudden Onset); Interval Stability; AV Association; Morphology Discrimination (Far Field MD™ Morphology Discrimination or Original MD) with Automatic Template Update
Monitor Mode| Detection; Discrimination; Diagnostics; No therapy delivery (VT or VT-1 zone)
Discrimination Modes| On; Passive; Off
SVT Upper Limit| 150-240 bpm
SVT Discrimination Timeout| 20s-60 min; Off
Reconfirmation| Continuous sensing during charging
SecureSense™ RV Lead Noise Discrimination Algorithm| On; On with Timeout; Passive; Off
VF Therapy Assurance| On; Off
Antitachycardia Pacing Therapy|
ATP Configurations| Ramp; Burst; Scan; 1 or 2 schemes per VT zone
ATP in VF Zone| ATP While Charging; ATP Prior to Charging; Off
ATP Upper Rate Cutoff| 150-300 bpm
Burst Cycle Length| Adaptive (50%-100%); Fixed (200-550 ms)
Min. Burst Cycle Length| 150-400 ms
Readaptive| On; Off
Number of Bursts| 1-15
Number of Stimuli| 2-20
Add Stimuli per Burst| On; Off
ATP Pulse Amplitude| 7.5 V independent from Bradycardia and Post-Therapy Pacing
ATP Pulse Width| 1.0 or 1.5 ms independently programmable from bradycardia and post-therapy pacing
High-Voltage Therapy|
DynamicTx™ Over-current Detection Algorithm| On; Off
DeFT Response™ Technology| Programmable pulse width for P1/P2 and tilt
High-Voltage Therapy|
---|---
High-Voltage Output Mode| Fixed Pulse Width; Fixed Tilt
Waveform| Biphasic; Monophasic
RV Polarity| Cathode (-); Anode (+)
Electrode Configuration| RV to Can; RV to SVC/Can; RV to SVC
Bradycardia Pacing|
Permanent Modes| DDD(R); DDI(R); VVI(R); AAI(R); Off
Temporary Modes| DDD; DDI; VVI; AAI; AAT; DOO; VOO; AOO; Off
Activity Sensor| On; Passive; Off
Programmable Rate and Delay Parameters| Base Rate (bpm); Rest Rate (bpm); Maximum Tracking Rate (bpm); Maximum Sensor Rate (bpm); Paced AV Delay (ms); Sensed AV Delay (ms); Rate Responsive AV Delay; Hysteresis Rate (bpm); Rate Hysteresis with Search
Pulse Amplitude| 0.25-7.5 V
Pulse Width| 0.05 ms; 0.1-1.5 ms
Ventricular AutoCapture™ Pacing System| On; Off
ACap™ Confirm Feature| On; Monitor; Off
QuickOpt™ Timing Cycle Optimization| Sensed/Paced AV delay
Auto Mode Switch (AMS)| DDI(R); VVI(R); Off
Atrial Tachycardia Detection Rate| 110-300 bpm
AMS Base Rate| 40; 45; … 135 bpm
Rate Responsive PVARP| Low; Medium; High; Off
Rate Responsive V Pace Refractory| On; Off
PAC Response| On; Off
PAC Response Interval| 200-400 ms
PMT Detection/Termination| Atrial Pace; Passive; Off
Ventricular Intrinsic Preference (VIP™)| On (50-200 ms); Off
Post-Therapy Pacing (Independently programmable from Bradycardia and ATP)
Post-Shock Pacing Mode| AAI; VVI; DDI; DDD; Off
Post-Shock Base Rate| 30-100 bpm
Post-Shock Pacing Duration| 0.5; 1; 2.5; 5; 7.5; or 10 min; Off
Device Testing/Induction Methods|
DC Fibber™ Induction Method Pulse Duration| 0.5-5.0 sec
Burst Fibber Cycle Length| 20-100 ms
Noninvasive Programmed Stimulation (NIPS)| 2-25 stimuli with up to 3 extra stimuli
Patient Notifiers|
---|---

Programmable Notifiers (On; Off)

| BatteryAssurance™ alert; Possible HV circuit damage; HV charge timeout; Long charge time for Capacitor Maintenance; Device at ERI; Atrial pacing lead impedance out of range. Ventricular pacing lead impedance out of range; High- voltage lead impedance out of range; AT/AF Episode duration; AT/AF Burden; High ventricular rate during AT/AF; SecureSense™ lead noise detection; Non- sustained ventricular oversensing; Ventricular pacing percentage greater than limit
Device Parameter Reset| On
Entry into Backup VVI Mode| On
Auditory Duration| 2; 4; 6; 8; 10; 12; 14; 16 sec
Number of Audio alerts per Notification| 2
Number of Notifications| 1–16
Time Between Notifications| 10; 22 hours
Electrograms and Diagnostics|

Stored Electrograms

| Up to 15 minutes (2 user programmable + discrimination channel); up to one minute programmable pre- trigger data per VT/VF electrograms; additional triggers include lead noise detection; non-sustained ventricular oversensing; morphology template updates; atrial episode; PMT termination; PAC response; magnet reversion; noise reversion
Therapy Summary| Diagram of therapies delivered
Episodes Summary| Directory listing of up to 60 episodes with access to more details including stored electrograms
Lifetime Diagnostics| History of bradycardia events and device-initiated charging
AT/AF Burden Trend| Trend data and counts
Ventricular HV Lead Impedance| Multi-Vector Trend Data

Histograms and Trends

| Event Histogram; AV Interval Histogram; Mode Switch or AT/AF Duration Histogram; Peak Filtered Atrial Rate during Atrial Arrhythmia Histogram; Atrial Heart Rate Histogram; Ventricular Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending; V Rates during AMS; DirectTrend™ reports up to 1 year
PMT Data| Information regarding PMT detections
Real-Time Measurements (RTM)| Pacing lead impedances; High-voltage lead impedances; Signal amplitudes
CorVue™ Thoracic Impedance| On; Off
CorVue Thoracic Impedance Threshold| 8–18 days
MRI Settings|
Tachy Therapy| Disabled
MRI Mode| DOO; VOO; AOO; Pacing Off
MRI Base Rate| 30-100 bpm
MRI Paced AV Delay| 25-120 ms
MRI Pulse Amplitude| 5.0 or 7.5 V
MRI Pulse Width| 1.0 ms
MRI Pulse Configuration| Bipolar
MRI Timeout| 3; 6; 9; 12; 24 hours; Off
MRI SCAN PARAMETERS †

Lead Model| Magnet (Tesla)| RF Transmit Conditions| Scan Region
Durata™ Defibrillation Lead|

1.5 T / 3 T

|

Normal Operating Mode

|

Full-body

7120 (lead lengths: 60, 65 cm)
7122 (lead lengths: 60, 65 cm)
Optisure™ Lead|

1.5 T / 3 T

LDA220 (lead lengths: 60, 65 cm)
LDA210 (lead lengths: 60, 65 cm)
Tendril™ STS Pacing Lead|

1.5 T / 3 T

2088TC (lead lengths: 46, 52 cm)
Tendril™ MRI Lead|

1.5 T

LPA1200M (lead lengths: 46, 52 cm)
UltiPace™ Pacemaker Lead|

1.5 T / 3 T

LPA1231 (Lead lengths 46, 52 cm)

† For additional information about specific MR Conditional ICDs and leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events, please refer to the Abbott MRI-Ready Systems Manual at medical.Abbott/manuals.

Rx Only

Brief Summary: This product is intended for use by or under the direction of a Physician. Prior to using these devices, please review the Instructions for Use for acomplete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Intended Use : The Implantable Cardioverter Defibrillator (ICD) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation.
The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.
Indications : The ICD devices are indicated for automated treatment of life-threatening ventricular arrhythmias.
- In addition, dual chamber ICD devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.
- MR Conditional ICDs are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.
- The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.
Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
- The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.
- Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation,
- Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle),

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Tel : +1 818 362 6822
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Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shock while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device- programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, and Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.

No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.

FAQ

Q: Is the EntrantTM Dual Chamber ICD compatible with the myMerlinPulseTM app?
A: Yes, the device is compatible with the myMerlinPulseTM app for remote monitoring and data transmission.

Q: Can the device provide insights into the patient’s heart failure condition?
A: Yes, the device utilizes transthoracic impedance changes over time to offer additional insights into the patient’s heart failure condition.