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

Model Number	PM2136
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange procedure, the atrial set screw could not be loosened and the set screw appeared to be stripped.Additionally, the hex wrench would not fit into the set screw.The atrial lead was cut and the device was explanted to resolve the event.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
The reported event of could not untighten the atrial setscrew to remove the lead was confirmed.Analysis revealed that numerous incorrect wrench insertions by the user/physician resulted in excessive septum punchouts that landed in and filled the setscrew inset.The septum punchouts prevented the wrench tip from properly engaging the inset, causing it to slip and ultimately strip the inset during use by the physician.For lab testing the septum punchouts were removed from the setscrew inset.A wrench was inserted to engage the unstripped portion of the inset.The setscrew could be untightened normally, and the stuck atrial lead was removed from the connector header.The problem was caused by the incorrect wrench insertions by the user/physician.

• 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: 22102028
• Report Number: 2017865-2025-64930
• Device Sequence Number: 8139946
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)3737002(17)131231
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• 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): 07/14/2025

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: 12/31/2013
• Device Model Number: PM2136
• Device Lot Number: 3737002
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/12/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2012
• 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