MAUDE Adverse Event Report: ABBOTT PROMOTE PLUS CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3211-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the device was found to have reached its elective replacement indicator (eri) prematurely.Premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The field complaint of suspected premature battery depletion was not confirmed.A longevity calculation was performed based on the programmed settings and usage data.The calculation showed the battery depletion was normal.However, it was found that the longevity estimate given to the field by the programmer was incorrect.The device was at its elective replacement indicator (eri) when received.Testing was performed on the icd and the device was found to be normal; telemetry, pacing, sensing, impedance, high voltage output, high voltage shock, and patient notifier were tested on the bench.No anomaly was detected.The root cause for the inconsistent remaining longevity estimate near eri could not be conclusively determined.

• Brand Name: PROMOTE PLUS CRT-D
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8462406
• Report Number: 2938836-2019-02249
• Device Sequence Number: 14184547
• Product Code: NIK
• UDI-Device Identifier: 05414734503693
• UDI-Public: 05414734503693
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: CD3211-36
• Device Lot Number: 4166102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention