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	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a diagnostic anomaly resulting in missing battery diagnostic data was observed on the device.The device is anticipated to be explanted and replaced, but no intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.
Event or Problem Description
Additional information received indicated the device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of longevity anomalies and incorrect measurement was not confirmed.The device was received with normal output and normal telemetry communication.The device was interrogated with a merlin programmers and the battery voltage was still at normal range of operation.Electrical and mechanical tests performed including telemetry communication and outputs verification did not identify any functional issues.The device was implanted for more than 10 years which exceeds its projected longevity and is consistent with 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: 21866923
• Report Number: 2017865-2025-40521
• Device Sequence Number: 4719739
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)4570839(17)151031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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: 10/31/2015
• Device Model Number: PM2136
• Device Lot Number: 4570839
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/12/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2014
• 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