BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2012173 · Received February 1, 2011

    Report

    Report Number
    1644487-2011-00151
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A VNS TREATING PHYSICIAN REPORTED TO THEIR COUNTRY REPRESENTATIVE IN THE (B)(6) THAT THEY HAD A PATIENT WITH HIGH LEAD IMPEDANCE ON THEIR NORMAL MODE DIAGNOSTIC TESTING. HIGH IMPEDANCE: (B)(6) 2010, 10.000 OHMS. THE PATIENT WAS ALSO HAVING HOARSENESS WITH STIMULATION ON TIME AND SHORTNESS OF BREATH WITH STIMULATION ON EXERTION. THE PATIENT'S VNS HAS BEEN PROGRAMMED OFF. THE PATIENT DID NOT HAVE EFFICACY WITH THEIR SEIZURES WITH THE VNS SO AT THIS TIME, NO REVISION SURGERY IS PLANNED. X-RAYS ARE GOING TO BE SENT TO THE MANUFACTURER FOR REVIEW. THE PATIENT PLAYS HOCKEY SO IT IS POSSIBLE HE HAD A FALL THAT MAY HAVE ATTRIBUTED TO THEIR HIGH LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 2284

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male