BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2933222 · Received January 29, 2013

    Report

    Report Number
    1644487-2013-00230
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT A VNS PATIENT WAS SEEN IN CLINIC AND THEY HAD HIGH LEAD IMPEDANCE. THE PATIENT WOULD BE REFERRED TO SURGERY. THERE WAS NO REPORT OF ANY TRAUMA OR MANIPULATION PRIOR TO THE EVENT. THE PATIENT IS DEVELOPMENTALLY DELAYED SO POSSIBLE. NO X-RAYS WERE TAKEN BUT THEIR VNS WAS DISABLED ON (B)(6) 2013. THE PATIENT'S NEUROLOGIST FOUND HIGH IMPEDENCE ON (B)(6) 2012 AND THEIR LAST VISIT ON (B)(6) 2012 SHOWED NORMAL DIAGNOSTIC RESULTS. THE PATIENT HAD FULL REVISION SURGERY ON (B)(6) 2013 AND THEIR PRODUCTS WERE DISCARDED THEREFORE WILL NOT BE RETURNED FOR ANALYSIS. A LEAD BREAK WAS NOT REPORTED TO HAVE BEEN SEEN IN THE SURGERY. A PIN REINSERTION WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38844 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200330

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR