MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5356
Medical Device Problem Codes	Pacing Intermittently (1443); Unexpected Mode Switch (4076)
Health Effect - Clinical Codes	Arrhythmia (1721); Dizziness (2194)
Date of Event	03/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was presented in the emergency room with arrhythmia and dizziness.Upon further interrogation, it was noted that the pacemaker had revert into back-up mode and pacing intermittently.The pacemaker was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed; pacing anomaly was not confirmed.The device was received with no output, no telemetry and battery at end of service (eos) level.The device image could not be saved due to lack of telemetry.The original battery was replaced, and the product code was downloaded successfully.The device was tested under nominal conditions with results indicating normal functionality.Additionally, evaluation of the output signal found all pacing parameter within normal range.Battery fluctuation test was performed, and the device voltage dropped below end of service level consistent with the backup operation noticed in the field.Longevity assessment was performed, based on nominal settings, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• 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: 21751692
• Report Number: 2017865-2025-39134
• Device Sequence Number: 15992953
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: (01)05414734006835(10)3466961(17)130228
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 05/02/2025

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: 02/28/2013
• Device Model Number: 5356
• Device Lot Number: 3466961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2011
• 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