Recall Z-2421-2018 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
| Date | Jul 10, 2018 (initiated Jun 21, 2018) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 p |
| Quantity | 1867 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.