BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2823231 · Received November 7, 2012

    Report

    Report Number
    1644487-2012-02915
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD A SUSPECTED VNS LEAD FRACTURE. NO KNOWN TRAUMA OCCURRED. REVISION OF THE VNS LEAD IS LIKELY, BUT HAS NOT OCCURRED TO DATE. THE PATIENT IS CURRENTLY ON A WAITING LIST FOR SURGERY.

    Description of Event or Problem · 1

    REPORTER INDICATED THE VNS WAS DISABLED WHEN THE HIGH LEAD IMPEDANCE WAS NOTED. THE VNS LEAD WAS REPLACED ON (B)(6) 2012. DIAGNOSTICS WITH THE NEW VNS LEAD AND RESIDENT GENERATOR WERE WITHIN NORMAL LIMITS PER THE IMPLANT CARD RECEIVED BACK TO THE MANUFACTURER. THE EXPLANTED LEAD WAS DISCARDED BY THE HOSPITAL. PATIENT X-RAYS MAY BE SENT IN TO REVIEW.

    Description of Event or Problem · 1

    X-RAYS WERE REPORTED AS SENT TO THE MANUFACTURER, BUT HAVE BEEN UNABLE TO BE LOCATED TO DATE AND ARE BELIEVED TO BE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 200411

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR