BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300

    MDR report key: 2043102 · Received March 25, 2011

    Report

    Report Number
    1644487-2011-00648
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED LEAD FRACTURE. DIAGNOSTICS ARE NOT AVAILABLE TO CONFIRM HIGH IMPEDANCE AND IT IS UNKNOWN WHY A LEAD FRACTURE IS SUSPECTED, BUT PER PHYSICIAN, THE PATIENT HAS BEEN EXPERIENCING PAIN AND HAS HAD AN INCREASE IN SEIZURES RECENTLY. IT WAS REPORTED THAT THE PATIENT FELL RECENTLY AND FRACTURED HER WRIST FROM SLIPPING ON ICE. THE GENERATOR IS ALSO CURRENTLY DEPLETED WHICH MAY BE CONTRIBUTING TO THE SEIZURES. HOWEVER, THE PATIENT DOES CLAIM TO STILL FEEL STIMULATION. X-RAYS OF THE DEVICE WERE TAKEN AND REVIEWED BY THE MANUFACTURER. BASED ON THE X-RAY IMAGES PROVIDED, NO LEAD FRACTURE WAS CONFIRMED, HOWEVER, THE PRESENCE OF A MICRO-FRACTURE OR LEAD DISCONTINUITY IN THE PORTION OF THE LEAD BEHIND THE GENERATOR CANNOT BE RULED OUT. THE PATIENT HAS BEEN REFERRED TO A SURGEON FOR POSSIBLE REVISION SURGERY. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5131

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other