Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Enforcement
- Recall Number
- Z-2418-2018
- Event ID
- 80379
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- July 18, 2018
- Initiation Date
- June 21, 2018
- Classification Date
- July 10, 2018
- Termination Date
- June 16, 2021
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States
Description
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
Product UPN/GTIN: 00885074300245 Serial Numbers: PNT402938H PNT413911H PNT413995H
Worldwide Distribution - US Nationwide
3 units