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

Model Number	PM2136
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in clinic follow up, the device was attempted to be interrogated however the device kept restarting the interrogation process on its own, resulting in the device being unable to be interrogated.Technical support was contacted and recommended further investigation via an additional in clinic follow up.No intervention has been performed at this time.The patient was stable and will continue being monitored.
Event or Problem Description
Additional information was received indicating the device was explanted and replaced to resolve the event.The patient was stable.
Event or Problem Description
Additional information received indicated an additional follow up appointment was performed.The device was able to be successfully interrogated but shortly after the interrogation would restart.No additional intervention was performed.
Additional Manufacturer Narrative
The reported event of inability to interrogate was not confirmed.The device was received with normal output and normal telemetry communication.Electrical and mechanical tests performed including telemetry communication and outputs verification did not identify any functional issues.There were no device anomalies found that could contribute to the reported events.Longevity assessment was performed, and the device voltage was at normal range of operation with appropriate remaining longevity.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18446362
• Report Number: 2017865-2024-00398
• Device Sequence Number: 7965326
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: 05414734504713
• 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
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/23/2024

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: 02/28/2017
• Device Model Number: PM2136
• Device Lot Number: S000010259
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 01/05/2024; 01/23/2024; 02/20/2024; 04/22/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 01/09/2024; 02/06/2024; 02/28/2024; 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown