BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1900320 · Received October 25, 2010

    Report

    Report Number
    1644487-2010-02405
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: REVIEW X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. CONCLUSIONS: DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE TREATING PHYSICIAN THAT THE VNS PATIENT'S DEVICE REVEALED HIGH LEAD IMPEDANCE, DCDC =7 ON BOTH SYSTEM AND NORMAL MODE DIAGNOSTIC TEST PERFORMED AT A FOLLOW UP VISIT. THE DEVICE WAS PROGRAMMED OFF. X-RAYS WERE TAKEN AND PROVIDED TO THE MANUFACTURER FOR REVIEW. REVIEW OF X-RAYS REVEALED THAT A LEAD FRACTURE IS SUSPECTED IN ONE OF THE QUADFILAR COILS OF THE LEAD IN THE STRAIN RELIEF BEND LOCATION, PRIOR TO THE LOCATION OF THE FIRST TIE-DOWN. THE NEUROLOGIST AND PT HAVE OPTED TO KEEP THE DEVICE DISABLED FOR ONE YEAR AND RE-ASSESS SURGICAL INTERVENTION AT THAT TIME. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE CURRENTLY UNDERWAY, HOWEVER, NO ADDITIONAL INFO HAS BEEN MADE AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 200754

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male