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

Model Number	5826
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Capturing Problem (2891)
Health Effect - Clinical Codes	Dyspnea (1816); Discomfort (2330)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during in clinic follow up that the atrial lead exhibited high capture threshold.The patient was experiencing diaphragm stimulation, discomfort and difficulty breathing.The lead and pacemaker were explanted and successfully replaced.
Additional Manufacturer Narrative
Correction: healthcare professional was not provided and shouldn't have been checked in g2.
Additional Manufacturer Narrative
The reported events of inadequate capture, and therapy delivered to incorrect body area were not confirmed.The device was above elective replacement indicator (eri) level upon receipt.The device triggered backup mode post explant consistent with exposure to cold temperature.Electrical and mechanical analysis performed after reloading the device code indicated normal functionality.Further analysis included capture test with results indicated normal capture performance.Additionally, visual inspection of the header did not find any contamination that could contribute to the reported events.Longevity assessment was performed, and the device was in normal range of operation with appropriate remaining longevity.

• Brand Name: ZEPHYR XL DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 22323477
• Report Number: 2017865-2025-89150
• Device Sequence Number: 8947753
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: (01)05414734501620(10)P000152485(17)240131
• 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: 2022
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 01/31/2024
• Device Model Number: 5826
• Device Lot Number: P000152485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/29/2025; Not provided; 02/26/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/02/2025; 09/05/2025; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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