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

Model Number	5620
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device battery had depleted prematurely.The patient was in for a routine follow-up and the device showed 1 plus year longevity, and next follow-up 3 months later device had triggered eri.The device was explanted.There were no adverse health consequences to the patient.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device was received operating in elective replacement indicator (eri).Device image indicated that voltage was above eri level during the whole implant duration and eri was falsely triggered due to auto capture being enabled, and the device was pacing at high output mode at times.When automatic settings are programmed, such as autocapture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.Further analysis performed found no anomaly.A longevity assessment was performed based on nominal settings and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ZEPHYR SR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18685371
• Report Number: 2017865-2024-22357
• Device Sequence Number: 15047868
• Product Code: NVZ
• UDI-Device Identifier: 05414734501606
• UDI-Public: 05414734501606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2024

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: 03/31/2018
• Device Model Number: 5620
• Device Lot Number: S000024698
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown