BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191833 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01660
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S VNS INDICATED HIGH IMPEDANCE DURING A ROUTINE OFFICE VISIT. THE PT'S VNS WAS DISABLED AS RECOMMENDED BY THE MFR. NO TRAUMA OR MANIPULATION WAS REPORTED BUT IT WAS NOTED THAT THE PT HAD A MAMMOGRAM SINCE THE PREVIOUS PT VISIT THAT COULD POSSIBLY HAVE DISTURBED THE DEVICE. THE PT'S DIAGNOSTICS WERE REPORTED TO BE OKAY AT THE PT'S LAST VISIT (B)(6) MONTHS AGO. CHEST X-RAYS WERE TAKEN AND FORWARDED TO THE MFR FOR REVIEW. REVIEW OF THE X-RAYS FOUND NO OBVIOUS ANOMALIES HOWEVER THE PORTION OF THE LEAD IN THE NECK COULD NOT BE EVALUATED FROM THE IMAGES AVAILABLE. THE SURGEON WAS INFORMED THAT SURGERY WOULD BE NECESSARY IF THE PT WISHES TO CONTINUE THERAPY. NO ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1538

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention