MAUDE Adverse Event Report: ABBOTT PROMOTE+ CRT-D W/SJ4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3211-36Q
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/ method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During follow-up, premature battery depletion was suspected.Session records were sent to abbott technical support for review which indicated a battery longevity overestimation by the programmer.The device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The device was returned due to suspected premature battery depletion and an overestimation of battery longevity.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 the elective replacement interval (eri) when received.Testing was performed on the icd and the device was found to be normal; telemetry, pacing, sensing, impedance, hv output, hv shock, and patient notifier were tested on the bench.No anomaly was detected.

• Brand Name: PROMOTE+ CRT-D W/SJ4 CONNECTOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10332319
• Report Number: 2938836-2020-07654
• Device Sequence Number: 19464347
• Product Code: NIK
• UDI-Device Identifier: 05414734503679
• UDI-Public: 05414734503679
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 04/30/2016
• Device Model Number: CD3211-36Q
• Device Catalogue Number: CD3211-36Q
• Device Lot Number: 4861008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: Required Intervention
• Patient Age: 84 YR