MAUDE Adverse Event Report: ABBOTT SUSTAIN XL DR; Pulse generator, permanent, implantable

Model Number	PM2136
Medical Device Problem Codes	Computer Software Problem (1112); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an in-clinic follow-up, the patient was feeling discomfort.After interrogation, the device was found to be in back-up mode (bvvi) due to bit flip.Additionally, during interrogation, while in bvvi, the model number was showing incorrect.The device had a firmware update which resolved the bvvi and corrected the model number in the programmer records event.The patient was stable with no consequences.

• 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 MEDICAL; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25111336
• Report Number: 2017865-2026-08970
• Device Sequence Number: 13350845
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)S000002688(17)160930
• 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: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: PM2136
• Device Lot Number: S000002688
• Was Device Available for Evaluation?: No
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2015
• 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
• Patient Sex: Unknown