BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 1921942 · Received December 8, 2010

    Report

    Report Number
    1644487-2010-02759
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECENTLY HAD TO HAVE SOME DENTAL SURGERY IN WHICH HE HAD TO HAVE AN ANESTHETIC. DURING SURGERY, THEY SECURED THE MAGNET ACROSS THE VNS IMPLANT TO TURN IT OFF. THIS HAS BEEN DONE BEFORE ON HIM AND HE HAS BEEN OK. HOWEVER, ON THIS OCCASION HIS SEIZURES HAVE DETERIORATED QUITE BADLY SINCE HAVING THIS TREATMENT. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other