Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRe

FDA device recall Z-2418-2018 · posted 2018-07-10 · Terminated

Recall details

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LWS

Quantity affected

3 units

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2018-06-21

Date posted

2018-07-10

Date terminated

2021-06-16

Location

Mounds View, MN