BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 1801194 · Received August 11, 2010

    Report

    Report Number
    1644487-2010-01851
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    March 1, 2010
    Report Date
    July 12, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PT THAT HER LEAD WIRES HAVE MOVED AROUND THE AREA OF HER LEFT COLLAR BONE AND SHE IS NOW EXPERIENCING PAIN AT THE NECK SITE. F/U WITH THE SURGEON REVEALED THAT EVERYTHING IS NORMAL AND PT PULLS AT HER WIRES SO, THERE IS GOING TO BE DISCOMFORT. DIAGNOSTICS ARE WITHIN NORMAL LIMITS. IT WAS ALSO REVEALED THAT THE PT HAD A SPINAL SURGERY LAST YEAR AND COULD HAVE LED TO THE DISPLACEMENT OF THE LEAD WIRES. REVISION SURGERY IS LIKELY.

    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 55 YR Female Required Intervention