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

Model Number	5820
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the standard generator changeout procedure, the patient experienced an arrhythmia and a loss of low voltage (lv) output due to electrocautery.The patient's pacemaker was successfully explanted and replaced.The patient was stable.

• Brand Name: ZEPHYR DR
• 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: 24971489
• Report Number: 2017865-2026-08433
• Device Sequence Number: 4954722
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: (01)05414734501613(10)S000074342(17)210630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• 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): 06/18/2026

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: 06/30/2021
• Device Model Number: 5820
• Device Lot Number: S000074342
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• 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 Sex: Unknown