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

Model Number	5820
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a device check, a slow heart rate was observed on the electrogram (egm).When initial device interrogation was attempted, no communication could be established, but after a few attempts interrogation was achieved.The device was found to be in backup mode.A premature battery depletion was suspected.The device was explanted and replaced.There were no adverse health consequences to the patient.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed, while the reported event of failure to interrogate and device in backup mode was confirmed.The device was in backup mode, and at end of service indicator (eos) level upon receipt consistent with the interrogation difficulty reported by the field.Review of the device image indicates code corruption, which triggered the backup operation.Further analysis showed that auto-capture was enabled.When automatic settings are programmed, such as auto-capture, the device output adjusts itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.Electrical analysis performed, after replacing the battery, indicated normal functionality.Additionally, device evaluation at various pulse amplitude measured current levels within normal range, and no indication of premature depletion was noted.The device was monitored with load for several days with normal results.Despite extensive testing, the source of code corruption could not be determined.A longevity assessment was performed based on the average drain current and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: ZEPHYR DR
• 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: 18851180
• Report Number: 2017865-2024-34282
• Device Sequence Number: 20715973
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• 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: 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 02/28/2018
• Device Model Number: 5820
• Device Lot Number: S000023160
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AV PLUS DX RV LEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female