MAUDE Adverse Event Report: ABBOTT ZEPHYR DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	5820
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device reached elective replacement indicator (eri) level faster than expected.The device was explanted and replaced to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
The reported event of longevity anomalies and premature battery depletion was not confirmed.The device was in backup mode when received.Analysis of the device image indicated the device was operated above eri level throughout the implant duration and reached end of service (eos) level after the explanted date, consistent with post explanted cold temperature exposure.The device was implanted beyond its projected longevity.At this stage, the battery¿s capacity is significantly reduced, and its voltage level is sensitive to variations in usage.These conditions can result in fluctuations of battery voltage level measurements, which affects the longevity estimates.After replacing the battery, electrical and mechanical test results indicated normal functionality.Device was implanted for 8.17 years which exceeded its projected longevity and is considered normal battery depletion.

• Brand Name: ZEPHYR 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18436375
• Report Number: 2017865-2024-00237
• Device Sequence Number: 15368782
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 09/30/2016
• Device Model Number: 5820
• Device Lot Number: A000003635
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2015
• 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