BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1192120 · Received October 7, 2008

    Report

    Report Number
    1644487-2008-02440
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    July 29, 2008
    Report Date
    September 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REFERENCE MDR NUMBER: 1644487-2008-02045. THE PT WAS IMPLANTED ON SEPT 13TH 2007. IT WAS REPORTED "PT WAS IMPLANTED 6 MOS AGO. DURING CONSULTATION IN MAY, IMPEDENCY WAS 3700 OHMS. IN JULY, THE PT HAD A REVISION FOR FIXING BACK ONE OF THE TIEDOWNS. THE SURGEON DIDN'T TOUCH THE ELECTRODES. NO INTERROGATION WAS PERFORMED IN OR". GOOD FAITH ATTEMPTS ARE BEING MADE FOR ADDITIONAL DETAILS PERTAINING TO THE PT'S SURGERY IN JULY TO FIX BACK ONE OF THEIR TIE DOWNS. THIS FAR NO FURTHER INFO HAS BEEN ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 16740

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R