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

Model Number	5816
Medical Device Problem Codes	Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the clinic for a scheduled follow up.Upon review, the pacemaker was found in backup vvi mode.The device could not be interrogated.The pacemaker was explanted and replaced.The patient's condition was stable throughout.
Additional Manufacturer Narrative
The reported event of device in backup mode was confirmed.The event of failure to interrogate was not confirmed.The pacemaker was returned for analysis.The device had no output signal and battery at end of service (eos) level upon receipt.Device image could not be saved due to low battery voltage.The device code was re-loaded successfully, after replacing the battery, and electrical analysis performed at nominal conditions indicated normal functionality without any interrogation issue.Further analysis of output signal found normal pacing parameters.Backup operation could not be reproduced, and the cause of backup mode could not be determined.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found via longevity assessment that the device did not meet longevity, indicating premature depletion.Drain current measurements were performed after cutting open the device and replacing the battery indicated current levels were within normal range.Additionally, the device was monitored for several days with load and voltage and current measured were normal.The original battery was analyzed by the manufacturer and results were normal.Despite extensive testing the cause of premature battery depletion could not be determined.

• 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: 18149696
• Report Number: 2017865-2023-52505
• Device Sequence Number: 20488515
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: 05414734009553
• 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: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: 05/31/2018
• Device Model Number: 5816
• Device Lot Number: P000038408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2016
• 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