BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1153358 · Received September 5, 2008

    Report

    Report Number
    1644487-2008-02165
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    January 1, 2007
    Report Date
    August 6, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT EXPERIENCED PAINFUL STIMULATION IN THE NECK AND SHOULDERS, WHICH RESOLVED WHEN THE DEVICE WAS TURNED OFF. THE TREATING PSYCHIATRIST INDICATED DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. THE PATIENT WAS REFERRED TO A SURGEON FOR EVALUATION. THE SURGEON INDICATED THAT A CT SCAN SHOWED A "GAP" IN THE "WIRE." X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW, AND NO OBVIOUS LEAD DISCONTINUITIES WERE OBSERVED. FOLLOWUP WITH THE SURGEON REVEALED THAT HE PLANNED TO REPLACE THE LEAD EVEN THOUGH DEVICE DIAGNOSTICS ARE OK. HE INDICATED THAT THE CT SCAN SHOWED THE LEAD TO BE "FRAYED" AT THE CLAVICLE, WHERE THE PATIENT IS FEELING THE SHOCKING. REVISION SURGERY IS LIKELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention