BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3022028 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00821
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT FELL ON SOME ICE AND SINCE THAT TIME HE HAD AN INCREASE IN SEIZURES. DIAGNOSTICS WERE WITHIN NORMAL LIMITS AND THERE WAS NO DEVICE FAILURE SUSPECTED BY THE PHYSICIAN. IT IS UNKNOWN BY THE PHYSICIAN'S OFFICE THE CAUSE OF THE INCREASE IN SEIZURES OR IF THE SEIZURES ARE RELATED TO VNS. THE PATIENT PRIOR TO THIS FALL HAD 3-6 A MONTH AND THEN HAD MORE THAN THAT IN A COUPLE DATES. THE PATIENT CAME TO THE OFFICE ALREADY IMPLANTED WITH VNS SO IT WAS UNKNOWN IF THE INCREASE IN SEIZURE WERE ABOVE OR BELOW PER-VNS BASELINE. THE PATIENT HAD TWO SEIZURE TYPES, FALLS AND STARING. THE PATIENT HAS BEEN HAVING WHAT WAS REPORTED AS CONVULSIONS (FALL TYPE) BUT THERE WAS ALSO NOTED THAT THE PATIENT WAS HAVING A LOT OF SHAKING DUE TO THE PAIN OF THE BROKEN RIB FROM THE FALL SO SOME OF THE REPORTED "CONVULSIONS" MAY HAVE RELATED TO THE BROKEN RIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123354 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 201201

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR