Abbott CDVRA500T Single Chamber ICD Instruction Manual

: June 10, 2024
: Abbott

Table of Contents

Abbott CDVRA500T Single Chamber ICD
Product Information
Product Usage Instructions
Product Highlights
Ordering Information
Product Specifications
Rx Only
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Abbott CDVRA500T Single Chamber ICD

Abbott-CDVRA500T-Single-Chamber-ICD-Product

Product Information

Product Specifications

Model: GallantTM Single Chamber ICD CDVRA500T
Telemetry: Delivered/Stored Energy
Volume: 35 cc
Weight: 72 grams
Size: VOLUME (CC) 35
Defibrillation Lead Connections: Connector DEFIBRILLATION DF-1
Ventricular Sense/Pace Lead Connections: Connector SENSE/PACE IS-1

Product Usage Instructions

Overview
The GallantTM Single Chamber ICD CDVRA500T is an implantable cardioverter defibrillator device designed to monitor and treat irregular heart rhythms. Follow the guidelines below for proper usage.

Implantation Procedure

Consult with a qualified healthcare professional to determine if the device is suitable for you.
The device will be implanted under the skin near the collarbone through a surgical procedure.
Follow post-implantation care instructions provided by your healthcare provider.

Device Settings Adjustment
The device settings can be adjusted based on your specific medical needs. Consult with your healthcare provider for any necessary changes.

Monitoring and Maintenance
Regularly monitor the device for alerts or notifications. Contact your healthcare provider immediately if you receive any alerts regarding device status or performance.

FAQ

What should I do if I receive a BatteryAssuranceTM alert?
If you receive a BatteryAssuranceTM alert, contact your healthcare provider promptly for further evaluation and possible battery replacement.
How do I know if the Ventricular pacing lead impedance is out of range?
The device will notify you if the Ventricular pacing lead impedance is out of range. Contact your healthcare provider for assessment and potential repositioning of the leads.

Product Highlights

Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption
40J delivered energy safety shock option for an enhanced safety margin
DeFT Response™ technology offers noninvasive programming options to optimize rescue therapy to each patient’s unique physiology and changing conditions
VF Therapy Assurance decreases the time to treatment for arrhythmias in patients who are likely to be hemodynamically unstable
antitachycardia pacing (ATP) while charging and before charging in the VF zone extends the programming options for terminating tachyarrhythmias without a high-voltage shock
ShockGuard™ technology with DecisionTx™ programming is designed to reduce inappropriate therapy and minimize the need for programming adjustments at the implant
- SecureSense™ RV lead noise discrimination 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 is designed to 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 a high current is detected
MRI-Ready device tested in combination with an MR Conditional lead 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
The CorVue™ thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient’s heart failure condition
Dual patient notification: audio notification through the device and visual notification via the myMerlinPulse app

Ordering Information

Contents: Cardiac Pulse Generator

MODEL NUMBER| DIMENSIONS (L × W × H) (MM)| WEIGHT (G)| VOLUME (CC)| CONNECTOR DEFIBRILLATION| CONNECTOR SENSE/PACE
---|---|---|---|---|---
CDVRA500T| 73 × 51 × 12| 72| 35| DF-1| IS-1

See MRI Scan Parameters in MRI-Ready Systems Manual.

Product Specifications

PARAMETER SPECIFICATIONS

Post-Paced: Auto; 0.2-3.0 mV

Decay Delay| Post-Sensed: 0-220 ms

Post-Paced: 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| Sudden Onset, Interval Stability; Sinus Interval History; Morphology Discrimination (Far Field MD™ or Original MD) with Automatic Template Update
Discrimination Modes| On; Passive; Off
SVT Upper Limit| 150-240 bpm
SVT Discrimination Timeout| 20s-60 min; Off
Monitor Mode| Detection; discrimination; and diagnostics; no therapy delivery (VT or VT-1 zone)
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 Before 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 in increments of 5 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 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| Off; VVI(R)
Temporary Modes| Off; VVI; VOO
Activity Sensor| On; Passive; Off
Programmable Rate Parameters| Base Rate (bpm); Rest Rate (bpm); Maximum Sensor Rate (bpm); Hysteresis Rate (bpm); Rate Hysteresis with Search
Pulse Amplitude| 0.25-7.5 V
Pulse Width| 0.05, 0.1-1.5 ms
Ventricular AutoCapture™ Pacing System| On; Off
Rate Responsive V Pace Refractory| On; Off
Post-therapy pacing (Independently programmable from Bradycardia and ATP)
Post-Shock Pacing Mode| Off; VVI
Post-Shock Base Rate| 30-100 in increments of 5 bpm
Post-Shock Pacing Duration| Off; 0.5; 1; 2.5; 5; 7.5; or 10 min
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; Ventricular pacing lead impedance out of range; High-voltage lead impedance out of range; 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

| 30 minutes (1 user programmable + discrimination channel), up to 1-minute programmable pre-trigger data per VT/VF electrograms; additional triggers include lead noise detection, non-sustained ventricular oversensing, morphology template updates, 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
Trends| HV lead impedance; Ventricular pacing lead impedance; Ventricular signal amplitude; Ventricular capture threshold; Exercise and activity trending; DirectTrend™ reports up to 1 year
Histograms| Event Histogram; Ventricular Heart Rate Histogram
Real-Time Measurements (RTM)| Pacing lead impedances; High-voltage lead impedances; and Signal amplitudes
CorVue™ Thoracic Impedance| On; Off
CorVue Thoracic Impedance Threshold| 8-18 days
MRI Settings|
---|---
Tachy Therapy| Disabled
MRI Mode| VOO; Pacing Off
MRI Base Rate| 30-100 bpm
MRI Pulse Amplitude| 5.0 or 7.5 V
MRI Pulse Width| 1.0 ms
MRI Pulse Configuration| Bipolar
MRI Timeout| Off; 3; 6; 9; 12; 24 hours
MRI SCAN PARAMETERS †

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. Before using these devices, please review the Instructions for Use for a complete 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 the 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), 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 loss of 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 the use of the myMerlinPulse™ mobile application.

ABBOTT

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MAT-2400587 v1.0 | Item approved for U.S. only.