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	11/19/2019
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, it was noted that the device had reached elective replacement indicator (eri).The device was explanted and replaced due to suspected premature battery depletion.The patient was in stable condition.
Event or Problem Description
Additional information was received indicating device session records were sent to abbott technical support for review.Based on review of the device session records, the battery depletion of the device was normal.
Additional Manufacturer Narrative
As received, the device was not at eri.The reported field event of premature depletion was not confirmed.Longevity analysis found the battery depletion to be normal.No anomalies were found on the bench.

• 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: 9410753
• Report Number: 2938836-2019-16874
• Device Sequence Number: 2934460
• Product Code: NIK
• UDI-Device Identifier: 05414734503693
• UDI-Public: 05414734503693
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020

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: 06/30/2018
• Device Model Number: CD3211-36
• Device Catalogue Number: CD3211-36
• Device Lot Number: S000028095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/27/2019; 04/25/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/07/2020; 04/29/2020
• 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: Hospitalization; Required Intervention