MAUDE Adverse Event Report: ABBOTT ZEPHYR SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5620
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was found in backup mode.Device reprogramming was not possible due to normal battery depletion.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of device in backup mode was confirmed; the reported event of longevity anomaly was not confirmed.The device was received in backup condition and review of the device image indicates the pacer triggered backup mode consistent with code corruption caused by an unknown source.Additional information was requested to the field regarding exposure of the device to external source of energy and the field indicated no mri or x-rays were registered on that date.The device image indicates autocapture was enabled.When automatic settings are programmed, such as autocapture, the device output adjusts itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.The device code was re-loaded onto the pacer after replacing the battery and programmed to nominal conditions successfully.Electrical tests performed under nominal conditions indicate normal results.Further evaluation under various pulse amplitudes indicated normal functionality and no backup conditions could be reproduced.Longevity assessment was performed, and the pacer exceeded projected longevity indicating normal battery depletion.

• Brand Name: ZEPHYR SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13177437
• Report Number: 2017865-2022-00672
• Device Sequence Number: 4620401
• Product Code: NVZ
• UDI-Device Identifier: 05414734501606
• UDI-Public: 05414734501606
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 02/11/2022

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: 04/30/2015
• Device Model Number: 5620
• Device Catalogue Number: 5620
• Device Lot Number: 4317243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2013
• 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