MAUDE Adverse Event Report: ABBOTT VICTORY XL DR; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5816
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
During a normal device replacement procedure, the ventricular lead was unable to be removed from the device header.Multiple attempts were made but unsuccessful.Due to patient anatomy, the device was unable to be exchanged during the procedure.An additionally procedure occurred, and again, the ventricular lead was unable to be removed from the header.The lead was cut and replaced and a new device was able to be implanted to resolve the event.The patient was stable.
Additional Manufacturer Narrative
The reported event of failure to disconnect was confirmed.The device was in backup condition upon receipt which occurred post-explant consistent with exposure to cold temperature.Visual inspection of the header found the ventricular setscrew stripped off by the end-user caused by inserting the wrench tool at angles to the setscrew which damaged the ventricular setscrew.The device code was re-loaded successfully after replacing the original battery and output verification measured all pacing parameters within normal range.Longevity assessment was performed based on average drain current, and the device met projected longevity indicating normal battery depletion.

• Brand Name: VICTORY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 18047622
• Report Number: 2017865-2023-51336
• Device Sequence Number: 18161912
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: 05414734009553
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 01/08/2024

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: 12/31/2013
• Device Model Number: 5816
• Device Lot Number: 3719278
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 01/06/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown