BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4957000 · Received July 31, 2015

    Report

    Report Number
    1644487-2015-05389
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    August 1, 2014
    Report Date
    July 13, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PATIENT'S VNS DEVICE WAS DISABLED DUE TO PAINFUL STIMULATION AND LACK OF EFFICACY. PATIENT EXPERIENCED HEADACHE, PAIN IN THE CHEST, NECK AND RADIATING PAIN IN THE LEFT EAR WITH STIMULATION. SYSTEMS DIAGNOSTICS WERE PERFORMED AND HIGH IMPEDANCE WAS OBSERVED. ON (B)(6) 2015, THE PATIENT CAME BACK AND WANTED THE DEVICE TURNED ON. THE PATIENT HAD REPORTED INITIALLY THAT SHE DID NOT RECEIVE MUCH BENEFIT FROM VNS. ONCE THE DEVICE WAS DISABLED, THE PATIENT RETURNED AND SAID THAT SHE DID RECEIVE BENEFIT FROM IT AND THEREFORE THE VNS WAS TURNED BACK ON. PATIENT WAS REFERRED FOR X-RAYS BUT IT IS UNKNOWN OF THE DEVICE WAS TURNED ON AGAIN. PATIENT HAD PREVIOUSLY REPORTED HEADACHES, PAINFUL STIMULATION IN THE NECK AND FACE AND PULSATING AT THE GENERATOR SITE SINCE (B)(6) 2014. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502140 LEAD MODEL 302 LEAD MUZ CYBERONICS INC 302-20 1556

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR