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

Model Number	5620
Medical Device Problem Codes	Premature Discharge of Battery (1057); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the patient was previously seen on february 2024.And their pacemaker was noted, to have approximately 1.75 years of longevity remaining.During an in-clinic follow-up on october 30th.The patient's device was found in backup vvi.The backup state was unable to be recovered, as the battery resistance was 6 ohms.Premature depletion was suspected.The patient's device was removed and replaced.There were no patient consequences.
Event or Problem Description
It was reported that the patient was previously seen on february 2024 and their pacemaker was noted to have approximately 1.75 years of longevity remaining.During an in-clinic follow-up on october 30th, the patient's device was found in backup vvi.The backup state was unable to be recovered as the battery resistance was 6000 ohms.Premature depletion was suspected.The patient's device was removed and replaced.There were no patient consequences.
Additional Manufacturer Narrative
Device was returned due to being in backup mode.The backup condition of device was verified when received.Product code was downloaded, and analysis was performed.Analysis performed including telemetry and output featured of the device indicated that the pacer exhibited normal device characteristics.Device longevity calculation was performed and battery depletion was normal based on device usage.Analysis on the device image indicated the cause of backup was nmi trigger.The cause of nmi trigger was unknown and the reset could not be reproduced.

• 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: 20578947
• Report Number: 2017865-2024-68670
• Device Sequence Number: 8106278
• Product Code: NVZ
• UDI-Device Identifier: 05414734501606
• UDI-Public: (01)05414734501606(10)A000010070(17)170228
• 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: 2016
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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: 02/28/2017
• Device Model Number: 5620
• Device Lot Number: A000010070
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 01/10/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/12/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2015
• 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 Age: 81 YR
• Patient Sex: Female