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

Model Number	PM1136
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in clinic follow-up, the device was found to have reached elective replacement indicator (eri) and premature depletion was suspected.The device was explanted and replaced to resolve the event.The patient was stable.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The pacer was received in backup operation with battery voltage above elective replacement indicator (eri).Cautery marks were observed on pacer.The device was cut open for further analysis.Electrical and mechanical analysis was performed, including accelerated readings, which indicated normal device functionality.Battery analysis showed no anomaly and battery voltage above eri.False eri and battery voltage measurements in device image were consistent with erroneous data transfer.A longevity assessment was performed and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: SUSTAIN XL SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11564277
• Report Number: 2017865-2021-11993
• Device Sequence Number: 4147714
• Product Code: NVZ
• UDI-Device Identifier: 05414734504737
• UDI-Public: 05414734504737
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 10/31/2014
• Device Model Number: PM1136
• Device Catalogue Number: PM1136
• Device Lot Number: 4056353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 08/23/2021
• 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: Required Intervention