BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1760488 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01630
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    October 1, 2009
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WENT THROUGH SEVERAL MONTHS WITHOUT ANY SEIZURES UNTIL (B) (6) 2009 WHERE THE PT EXPERIENCED INCREASE IN SEIZURE ACTIVITY AFTER STANDING NEXT TO AN ELECTRICAL PANEL AT WORK. ADJUSTMENTS WERE MADE TO THE PT'S SETTINGS AT THAT TIME. THE PT HAS HAD A FEW MORE SEIZURES SINCE THAT TIME. CURRENTLY, THE PHYSICIAN HAS REFERRED THE PT FOR GENERATOR REVISION SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 6267

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention