BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 4182260 · Received October 17, 2014

    Report

    Report Number
    1644487-2014-02749
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    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

    AN ARTICLE TITLED "SAFETY OF A DEDICATED BRAIN MRI PROTOCOL IN PATIENTS WITH A VAGUS NERVE STIMULATOR" WAS RECEIVED STATING THAT PRIOR TO THE VNS PATIENT'S MRI, ABNORMAL DIAGNOSTIC RESULTS INDICATED A POTENTIAL LEAD BREAK. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661963 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1