BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 2974670 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00487
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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

    ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE REPLACEMENT SURGERY OCCURRED ON (B)(6) 2013. PRODUCT RETURN ATTEMPTS WERE MADE; HOWEVER, IT WAS STATED THAT EXPLANTED DEVICES GO THROUGH RISK MANAGEMENT AND ARE THEN DISCARDED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN'S OFFICE ON (B)(6) 2013 THAT HIGH LEAD IMPEDANCE WAS OBSERVED ON A SYSTEM DIAGNOSTIC TEST PERFORMED THAT DAY FOR THE PATIENT. IT WAS ALSO REPORTED THAT THE BATTERY WAS 'LOW' ACCORDING TO THE PHYSICIAN, WHICH MOST LIKELY REFERS TO THE IFI INDICATOR BEING SEEN. IT COULD NOT BE CONFIRMED IF THE PATIENT'S DEVICE WAS PROGRAMMED OFF AFTER THE HIGH IMPEDANCE WAS OBSERVED, BUT IT WAS STATED THAT THIS WAS TYPICALLY DONE WHENEVER HIGH IMPEDANCE IS SEEN. NO KNOWN TRAUMA AND NO CHANGES IN SEIZURES OR STIMULATION PERCEPTION WERE NOTED AS THE PATIENT WAS UNAWARE OF THE ISSUE. X-RAYS WERE TAKEN OF THE PATIENT; HOWEVER, THEY WILL NOT BE SENT TO THE COMPANY FOR REVIEW AND AN ANALYSIS OF THE IMAGES WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT IS SCHEDULED FOR SURGERY ON (B)(6) 2013. PER THE PHYSICIAN'S SITE, NO ADDITIONAL INFORMATION WILL BE PROVIDED AS IT IS AGAINST THE UNIVERSITY HOSPITAL'S POLICY. NO EXACT PROGRAMMING OR DIAGNOSTIC HISTORY WERE PROVIDED. A PROGRAMMING HISTORY REVIEW WAS PERFORMED; HOWEVER, THE LAST AVAILABLE DATA WAS FROM (B)(6) 2011. ATTEMPTS HAVE BEEN MADE FOR THE LEAD MODEL AND SERIAL NUMBER; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78264 LEAD MODEL UNK LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR