MAUDE Adverse Event Report: ABBOTT 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5366
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Codes	Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient passed away due to an unknown cause and after post mortem explantation, the device was found to be in backup vvi mode.Abbott technical support was contacted and noted the device had reached the elective replacement indicator (eri) and was approaching end of service (eos).It is currently unknown if the device caused or contributed to the patient's passing.Further information was requested but has not yet been received.
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Additional information received indicated the physician believed the battery longevity of the device was within the expected range and the device was not suspected to have caused or contributed to the patient's passing; however, the device was returned for analysis to ensure it was functioning properly during the patient's passing.
Additional Manufacturer Narrative
The event of the pacemaker being in back-up mode was confirmed.The device was received in backup operation.The backup operation was triggered after explant and is consistent with cold temperature exposure.Analysis was performed after installing a new battery.No anomalies were noted.The original battery was depleted to end of life (eol).A longevity assessment was performed, and the device¿s implanted duration exceeded projected longevity and is considered normal battery depletion.

• Brand Name: 5366, INTEGRITY DR, AB 20 73 559
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10766972
• Report Number: 2017865-2020-16904
• Device Sequence Number: 13734730
• Product Code: DXY
• UDI-Device Identifier: 05414734006866
• UDI-Public: 05414734006866
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2021

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: 04/30/2008
• Device Model Number: 5366
• Device Catalogue Number: 5366
• Device Lot Number: 2976765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 01/25/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/18/2020; 01/27/2021
• 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: Death