Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC P

Is my product affected?

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 automat

• UPC 00885074300245

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling three EnTrust SingleChamber Implantable Cardioverter Defibrillators with specific serial numbers due to a potential safety issue. As these devices approach the end of their battery life, they may suddenly display an End of Life alert without first providing a warning alert. When this happens, the device's battery may not have enough capacity to charge the high voltage circuits properly, which could take an excessive amount of time to complete.

This battery charging problem could result in a loss of high voltage therapy and anti-tachycardia pacing therapy, meaning the device may not be able to deliver needed treatment to correct dangerous heart rhythms. The three affected devices were distributed worldwide, including throughout the United States. The source document does not specify what remedy an affected consumer should pursue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Distribution - US Nationwide Quantity: 3 units Lot/code info: Product UPN/GTIN: 00885074300245 Serial Numbers: PNT402938H PNT413911H PNT413995H

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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