BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1964134 · Received January 11, 2011

    Report

    Report Number
    1644487-2011-00041
    Event Type
    Death
    Date Received
    January 11, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN EPILEPSY PT TO MFR'S EMPLOYEE AT (B)(6) IN (B)(6) THAT HER FRIEND HAD VNS IMPLANTED AND SUBSEQUENTLY DIED OF SEIZURE. NO MENTION OF VNS AS A CAUSE OF DEATH WAS PROVIDED. THE RPTR REQUESTED TO REMAIN ANONYMOUS AND PREFERRED TO NOT BE CONTACTED BY THE MFR FOR F/U AS SHE DOES NOT HAVE ANY ADD'L DETAILS TO PROVIDE. MFR PERFORMED A SEARCH WITH THE NAME (B)(6) WITH THE EVENT AS DEATH BUT DID NOT FIND ANY RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death