MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) VICTORY XL DR; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5816
Medical Device Problem Codes	Premature Discharge of Battery (1057); Capturing Problem (2891); Inappropriate or Unexpected Reset (2959); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional regulatory report submitted for correction of h6 codes.
Additional Manufacturer Narrative
The reported event of device in backup-mode was confirmed.Capturing problem, and premature discharge of battery were not confirmed.The device was in backup mode upon receipt consistent with low battery fluctuation, and battery at end of service level.Electrical test performed after replacing the battery indicated normal functionality and all pacing parameters were within normal range.Further evaluation at various pulse amplitude measured current level within normal range and no indication of premature depletion was noticed.Longevity assessment was performed based on average drain current and the device exceeded seventy-five percent of projected longevity indicating normal battery depletion.No other anomalies were found.
Event or Problem Description
It was reported patient's pacemaker inappropriately went into backup mode.The device exhibited high output voltage rates which caused premature battery depletion.The pacemaker was explanted and replaced successfully.Patient was stable.

• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21199989
• Report Number: 2017865-2025-10976
• Device Sequence Number: 7544822
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: (01)05414734009553(10)P000075852(17)200831
• 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: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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: 08/31/2020
• Device Model Number: 5816
• Device Lot Number: P000075852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 04/11/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/03/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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