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

Model Number	5820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported that the patient expired due to unknown cause.The death was reported without clear information as to whether the death was device related.Further information was requested but not received.
Additional Manufacturer Narrative
The device was returned due to patient death.The results of electrical, stress/environmental tests performed indicated that the pacer exhibited normal device characteristics.Longevity assessment was performed based on field settings and was in the normal range of operation with appropriate remaining longevity.Device image was successfully saved.

• 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: 19173769
• Report Number: 2017865-2024-39511
• Device Sequence Number: 7085849
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: (01)05414734501613(10)S000079646(17)220531
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 5820
• Device Lot Number: S000079646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• 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: Death
• Patient Sex: Female