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

Model Number	5820
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during implant procedure that the pacemaker exhibited high battery resistance.The device was successfully exchanged.There were no patient consequences.
Additional Manufacturer Narrative
The reported event of high battery impedance was confirmed.The device was received from the field with battery voltage above elective replacement level.The pacer was located at hakata, japan where the local temperature was around 10°c at the time of the event.The device was soaked at the same temperature and high cell impedance was reproduced.Further analysis was performed, including vibration and temperature cycle test, and results were normal with cell impedance within normal range.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ZEPHYR DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16035949
• Report Number: 2017865-2022-50491
• Device Sequence Number: 17940377
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/07/2023

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: 12/31/2022
• Device Model Number: 5820
• Device Catalogue Number: 5820
• Device Lot Number: S000082891
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 12/26/2022; 01/31/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 12/28/2022; 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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