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

Model Number	PM2136
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
During an in clinic follow up, the device was unable to be interrogated.It was noted, the patient had received cancer radiation therapy, it is unknown if this was the cause of in the inability to interrogate the device.It was also noted; the patient had not had a device check in a long time.The device was explanted and replaced to resolve the event.The patient was stable.
Additional Manufacturer Narrative
The reported event of failure to interrogate was not confirmed.The device was in back-up operation mode upon receipt.Analysis of the device image showed device went into backup while implanted due to exposure to radiation during treatment.The device was restored by reloading product code.Analysis performed indicated normal device characteristics, and device can interrogate through inductive telemetry throughout the tests.Longevity assessment was performed, and implant duration exceeds total 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: 23865242
• Report Number: 2017865-2025-1007808
• Device Sequence Number: 17475561
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)4547017(17)151031
• 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: 2014
• 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): 02/16/2026

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: 10/31/2015
• Device Model Number: PM2136
• Device Lot Number: 4547017
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2014
• 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: Female