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

Model Number	PM2136
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, the device was found to be in backup vvi mode (bvvi).Technical support was contacted and a firmware download was attempted, however it could not be completed.Further intervention was planned, but not yet performed.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Event or Problem Description
Additional information was received that the device was explanted and replaced to resolve the event.The patient was in stable condition.

• 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: 19383309
• Report Number: 2017865-2024-42135
• Device Sequence Number: 14402315
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)S000030527(17)180831
• 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: 2017
• 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): 06/19/2024

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: 08/31/2018
• Device Model Number: PM2136
• Device Lot Number: S000030527
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2017
• 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