BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1062865 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01418
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. NO GROSS LEAD DISCONTINUITIES VISUALIZED. TIE-DOWN WAS DISENGAGED FROM LEAD BODY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PT THOUGHT THE LEAD WAS KNOTTED UP IN HER NECK. X-RAYS WERE SENT TO THE MFR. A REVIEW OF THE X-RAYS REVEALED NO DISCONTINUITIES IN THE LEAD BODY OR VNS SYSTEM. IT WAS NOTED IN THE X-RAYS THAT ONE OF THE THREE TIE-DOWNS PRESENT HAD BECOME DISENGAGED FROM THE LEAD BODY. HER TREATING PSYCHIATRIST INDICATED DIAGNOSTICS SHOWED THE DEVICE TO BE FUNCTIONING PROPERLY. ADD'L INFO FROM ANOTHER PSYCHIATRIST REVEALED THAT THE PT IS SEARCHING FOR A SURGEON TO REVISE HER LEAD AS SHE BELIEVES TO BE "LOOSE." GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-30

    Patients

    Seq Age Sex Outcome Treatment
    1 Other