MAUDE Adverse Event Report: ABBOTT 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	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an in-clinic follow-up, elective replacement indicator (eri) was observed on the device due to suspected premature battery depletion (pbd).Technical services reviewed the patient's records and the pbd was not confirmed.A revision procedure was performed.The device was explanted and replaced to resolve the event.The patient is stable with no consequences.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device battery voltage was above elective replacement indicator (eri) level upon receipt.Analysis of device image indicated device was within normal range of operation.Autocapture was noted.When automatic settings are programmed, such as autocapture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.Further analysis performed, including vibration testing found no anomaly.Longevity assessment was performed, and device was at near elective replacement indicator level with appropriate remaining longevity.

• Brand Name: ZEPHYR XL DR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 23358774
• Report Number: 2017865-2025-1003015
• Device Sequence Number: 8815934
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: (01)05414734501620(10)3478343(17)130228
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 5826
• Device Lot Number: 3478343
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2011
• 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