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

Model Number	5256
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in the clinic.During the interrogation, it was noted that the pacemaker was in back-up mode.The pacemaker was explanted and replaced.The patient was stable throughout.
Additional Manufacturer Narrative
The reported event of device in backup mode was confirmed.Final analysis found that as received, the device was without telemetry and the battery reached end of service (eos).The device image could not be saved due to lack of telemetry.After replacing the battery, the device code was re-loaded successfully, and the device programmed and tested under nominal conditions and results indicated normal functionality.Results from battery fluctuation test indicated the battery voltage dropped below elective replacement indicator (eri) level which is consistent with the backup event observed in the field.Longevity assessment was performed, based on nominal settings, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: VERITY ADX XL
• 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: 18987751
• Report Number: 2017865-2024-37036
• Device Sequence Number: 8208943
• Product Code: DXY
• UDI-Device Identifier: 05414734501712
• UDI-Public: 05414734501712
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 05/31/2015
• Device Model Number: 5256
• Device Lot Number: 4336708
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2013
• 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