—#165306

Product

Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980016
Affected lot / code info: Product UPN/GTIN: 00721902791130 Serial Numbers: PNR100502Q PNR100510Q PNR100522Q PNR100535Q Product UPN/GTIN: 00721902791147 Serial Numbers: PNR100129Q PNR100130Q PNR100131Q PNR100134Q PNR100135Q PNR100138Q PNR100139Q PNR100141Q PNR100143Q PNR100144Q PNR100146Q PNR100147Q PNR100150Q PNR100151Q PNR100153Q PNR100154Q PNR100155Q PNR100156Q PNR100157Q PNR100160Q PNR100161Q PNR100162Q PNR100163Q PNR100164Q PNR100165Q PNR100166Q PNR100167Q PNR100168Q PNR100169Q PNR100174Q PNR100175Q PNR100176Q PNR100178Q PNR100182Q PNR100183Q PNR100184Q PNR100185Q PNR100188Q PNR100191Q PNR100192Q PNR100193Q PNR100195Q PNR100196Q PNR100197Q PNR100198Q PNR100200Q PNR100204Q PNR100208Q PNR100210Q PNR100211Q PNR100212Q PNR100213Q PNR100215Q PNR100216Q PNR100217Q PNR100218Q PNR100219Q PNR100220Q PNR100221Q PNR100222Q PNR100223Q PNR100224Q PNR100225Q PNR100226Q PNR100227Q PNR100228Q PNR100229Q PNR100230Q PNR100233Q PNR100234Q PNR100236Q PNR100237Q PNR100238Q PNR100239Q PNR100241Q PNR100242Q PNR100243Q PNR100244Q PNR100245Q PNR100247Q PNR100249Q PNR100252Q PNR100253Q PNR100254Q PNR100256Q PNR100259Q PNR100261Q PNR100262Q PNR100263Q PNR100264Q PNR100266Q PNR100267Q PNR100270Q Product UPN/GTIN: 00885074299907 Serial Numbers: PNR419863H Product UPN/GTIN: 00885074300207 Serial Numbers: PNR406072H PNR406348H PNR406416H PNR407438H PNR407439H

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

On 21-Jun-2018, Medtronic began notifying US follow-up physicians, and Risk Managers of health care facilities of this issue via hand delivery by Field Representatives. In consultation with an Independent Physician Quality Panel, MDT recommends the physicians following patients with affected devices: " Consider scheduling an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps described below. " Use a programmer to ensure the Excessive Charge Time EOL&and the Low Battery Voltage ERI& Patient Alerts have been programmed to On-High " Instruct patients to contact your office if they hear device alert tones. " If this issue has occurred, an EOL: replace device immediately Observation will be displayed on the programmer QuickLook report. Schedule device replacement immediately. The notification provided Patient Management recommendations to ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61V ERI threshold.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide

Timeline

Recall initiated: 2018-06-21
Posted by FDA: 2018-07-10
Terminated: 2021-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.