MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) VICTORY XL DR; implantable pacemaker Pulse-generator

Model Number	5816
Medical Device Problem Code	Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for in clinic follow-up with the pulse generator in backup operation due to battery exhaustion.Upon further assessment it was noted that high capture threshold was exhibited by the right ventricular lead, which caused the generator to operate at high output.The physician attributed the high capture threshold to patient anatomy.The patient was scheduled for replacement on (b)(6) 2024.The lead was capped, and the generator was explanted.There were no patient consequences.

• Brand Name: VICTORY XL DR
• Common Device Name: implantable pacemaker Pulse-generator
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19656825
• Report Number: 2017865-2024-58321
• Device Sequence Number: 6848287
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: (01)05414734009553(10)P000066244(17)200229
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: 02/29/2020
• Device Model Number: 5816
• Device Lot Number: P000066244
• 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: 06/10/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2018
• 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