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

Model Number	5826
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pacemaker (pm) exhibited premature battery depletion.The physician explanted and replaced the pm.The patient condition was stable.
Event or Problem Description
It was reported that the pacemaker (pm) exhibited premature battery depletion.Additionally, the right atrial (ra) lead failed to capture.The physician explanted and replaced the pm and ra lead.The patient condition was stable.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device was at elective replacement indicator (eri) level upon receipt.The device was also in backup mode which occurred post-explant consistent with exposure to cold temperature.Review of the device image indicates the device was programmed to high settings.The device code was re-loaded and programmed to nominal settings normally.Electrical tests performed indicated normal functionality.Additional evaluation at various pulse amplitudes measured normal current levels and no indication of premature depletion noted.Longevity assessment was performed based on field settings, and the device exceeded projected longevity indicating normal battery depletion.

• 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: 23710880
• Report Number: 2017865-2025-1006491
• Device Sequence Number: 16100907
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: (01)05414734501620(10)P000114550(17)220630
• 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: 2021
• 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,Followup
• Report Date (Section B): 03/25/2026

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: 06/30/2022
• Device Model Number: 5826
• Device Lot Number: P000114550
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/06/2025; 03/06/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/24/2025; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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