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

Model Number	5620
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for routine in-clinic follow-up.Interrogation of the pulse generator revealed that the device was in backup operation.Restoring the device was not recommended due to the high battery impedance.No interventions were made.The patient was stable.
Additional Manufacturer Narrative
The reported event of backup mode was confirmed.As received, the device was in backup operation due to low battery voltage.A review of the device image indicated corruption due to an attempted download in the field.After the battery was replaced, the pacemaker exhibited normal device characteristics.The implant duration exceeded the projected longevity based on average monthly current and is consistent with normal battery depletion.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
New information received notes that the pulse generator was explanted.Further information was requested but not received.

• 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: 18280455
• Report Number: 2017865-2023-94093
• Device Sequence Number: 6207067
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2024

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: 06/30/2018
• Device Model Number: 5620
• Device Lot Number: S000028368
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/22/2024; Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 02/14/2024; 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2017
• 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