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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was to receive an emergency replacement of the pacemaker due to the battery being dead.The pacemaker had been implanted for 8.5 yrs.The last battery voltage on (b)(6) 2023 was 2.69v and getting closer to the elective replacement indicator (eri).On the (b)(6) 2023 the battery was found dead leading the patient to be scheduled for the emergency replacement.Information received suggests a plausible 10 yr warranty request.A confirmation that the scheduled replacement procedure had occurred was requested but was not yet available.

• 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: 17344352
• Report Number: 2017865-2023-36165
• Device Sequence Number: 17764392
• Product Code: NVZ
• UDI-Device Identifier: 05414734501606
• UDI-Public: 05414734501606
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: 08/31/2015
• Device Model Number: 5620
• Device Catalogue Number: 5620
• Device Lot Number: 4458626
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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