BEUDAMED
    FDA Adverse Event Death Summary report: N

    VNS THERAPY PULSE

    MDR report key: 539124 · Received August 13, 2004

    Report

    Report Number
    1644487-2004-00667
    Event Type
    Death
    Date Received
    August 13, 2004
    Date of Event
    July 3, 2004
    Report Date
    July 22, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT HAD PASSED AWAY. THE PT WAS FOUND DEAD IN THEIR BED. THE PT HAD REPORTEDLY EXPERIENCED A FALL THAT DAMAGED THE NCP SYSTEM AND UNDERWENT GENERATOR REPLACEMENT SURGERY 11 DAYS PRIOR TO DEATH. IT IS NOT KNOWN WHETHER THE PT'S NEW GENERATOR WAS PROGRAMMED TO ON FOLLOWING THE GENERATOR REPLACEMENT SURGERY AND WHETHER OR NOT THE PT WAS RECEIVING VNS THERAPY AT THE TIME OF DEATH. AN AUTOPSY WAS PERFORMED DURING WHICH THE BIPOLAR LEAD WAS NOTED TO BE INTACT. CAUSE OF DEATH IS NOT KNOWN AT THIS TIME. TREATING PHYSICIAN INDICATED THAT THE RELATIONSHIP BETWEEN THE NCP SYSTEM AND THE REPORTED EVENT WAS UNKNOWN. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE. THERE IS NO EVIDENCE AT THIS TIME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102R 9946

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death LOT NO. ED-1217. MEDICATIONS AT TIME OF DEATH| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE| 01/09/1996, DATE OF MFG 12/27/1993, STERILIZATION| INCLUDE: VALPROATE/VALPROIC ACID, OXACARBAZEPINE.