BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 403612 · Received July 3, 2002

    Report

    Report Number
    1644487-2002-00306
    Event Type
    Death
    Date Received
    July 3, 2002
    Date of Event
    February 1, 2002
    Report Date
    March 20, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE PROCESS OF COORDINATING GENERATOR REPLACEMENT SURGERY PRIOR TO END OF SERVICE, MFR WAS NOTIFIED THAT PT HAD PASSED AWAY. THE PT'S GENERATOR WAS NOT REPLACED PRIOR TO THEIR DEATH. DEVICE DIAGNOSTIC TESTING AT LAST OFFICE VISIT (12/2001) WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THAT TIME. PHYSICIAN PLANNED TO SEE THE PT AGAIN IN 3/2002 AND REFER PT TO NEUROSURGEON FOR GENERATOR REPLACEMENT AT THAT TIME. ATTEMPTS TO CONTACT THE PT ON WITHIN 3 DAYS IN 02/2002 WERE UNSUCCESSFUL AND THE PT DID NOT KEEP THEIR APPOINTMENT WITH THE PHYSICIAN ON 03/2002. IT WAS LATER DISCOVERED THAT THE PT HAD PASSED AWAY. EXACT DATE AND CAUSE OF DEATH ARE UNKNOWN AT THIS TIME. THE PT WAS REPORTEDLY RECEIVING VNS THERAPY AT THE TIME OF DEATH. THE PHYSICIAN INDICATED THAT THE RELATIONSHIP BETWEEN THE CAUSE OF DEATH AND THE NCP SYSTEM IS UNKNOWN AT THIS TIME. IT IS UNKNOWN AT THE TIME WHETHER AN AUTOPSY WAS PERFORMED. ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 4887C

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death KEPPRA.| MEDICATIONS AT TIME OF DEATH: CARBAMAZEPINE,| DATE OF MFG 05/13/98, STERILIZATION LOT NO.11151C.| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 5/31/00,