MAUDE Adverse Event Report: ABBOTT ENDURITY SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	PM1160
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, the device was found to have entered backup vvi (bvvi) mode.Abbott technical support was contacted, and the device was reprogrammed; however, the device reverted back to bvvi mode 14 hours later.The device was then explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of pacemaker found in backup mode could not be confirmed.The pacer was received in normal working conditions with battery voltage above elective replacement indicator (eri).Electrical and mechanical analysis performed, indicated normal device functionality.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ENDURITY SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15502268
• Report Number: 2017865-2022-39703
• Device Sequence Number: 12795396
• Product Code: NVZ
• UDI-Device Identifier: 05414734507042
• UDI-Public: 05414734507042
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 03/31/2016
• Device Model Number: PM1160
• Device Catalogue Number: PM1160
• Device Lot Number: 4800815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown