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

Model Number	5816
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine device exchange procedure, the device lost pacing due to electrocautery and the patient entered asystole.The leads were quickly detached from the device and connected to an external pacemaker to resolve the arrhythmia.A replacement device was then implanted without further complication.The patient was in stable condition.
Additional Manufacturer Narrative
Further information was requested but not received.

• 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: 19615986
• Report Number: 2017865-2024-57867
• Device Sequence Number: 20576564
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: (01)05414734009553(10)3670408(17)131031
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 5816
• Device Lot Number: 3670408
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2012
• 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: Other
• Patient Sex: Unknown