MAUDE Adverse Event Report: ABBOTT SUSTAIN XL DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM2136
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a false elective replacement indicator (eri) alert was observed on the device.The device was explanted and replaced to resolve the event, and the patient was in stable condition.
Additional Manufacturer Narrative
The reported event of diagnostic anomaly was not confirmed.The device was in backup mode with battery voltage at end of service (eos) level upon receipt.The device triggered backup operation post-explant consistent with exposure to cold temperature.Review of the device image indicates auto-capture was enabled, and the device was in high output mode at times consistent with false elective replacement indicator (eri) alert triggered in the field.When automatic settings are programmed, such as auto-capture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.Electrical tests performed, after replacing the battery, and re-loading the device code, indicated normal functionality with normal measurements.Further evaluation of the output signal found all parameters within normal range.A longevity assessment was performed, based on field settings, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: SUSTAIN XL DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21191504
• Report Number: 2017865-2025-11167
• Device Sequence Number: 17011047
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)3737002(17)131231
• 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 Implanted Year: 2012
• Device Explanted Year: 2024
• 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): 03/24/2025

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: 12/31/2013
• Device Model Number: PM2136
• Device Lot Number: 3737002
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2012
• 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