MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) ZEPHYR XL SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	5626
Medical Device Problem Codes	Break (1069); Pacing Problem (1439)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pacemaker (pm) was at normal elective replacement indicator (eri) and during the pm change procedure, the pm had fully died due to cautery short circuited of the battery.The pm was explanted and replaced on (b)(6) 2026.No patient symptom was reported.
Additional Manufacturer Narrative
Further information was requested but not yet received.
Additional Manufacturer Narrative
The reported event of material integrity problem was not confirmed.The device was at end of service (eos) level upon receipt.Review of the device image indicates it was corrupted consistent with exposure to electrocautery during the explant procedure.Electrical test performed after replacing the battery indicated normal functionality.Longevity assessment was performed and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: ZEPHYR XL SR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24908532
• Report Number: 2017865-2026-08035
• Device Sequence Number: 9928878
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: (01)05414734501712(10)A000019300(17)170930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 5626
• Device Lot Number: A000019300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 05/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/11/2026; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2016
• 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
• Patient Age: 87 YR
• Patient Sex: Female