BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1832117 · Received September 3, 2010

    Report

    Report Number
    1644487-2010-02012
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HIGH LEAD IMPEDANCE WAS FOUND WHILE PERFORMING SYSTEMS AND NORMAL MODE DIAGNOSTICS ON A PATIENT'S VNS DURING AN OFFICE VISIT ON (B)(6)2010. THE REPORTER STATED THAT THE PATIENT'S VNS DIAGNOSTICS ON (B)(6)2010 WERE WITHIN NORMAL LIMITS, HOWEVER, THE EXACT DIAGNOSTICS WERE NOT PROVIDED. THE PATIENT DID NOT RECALL ANY MANIPULATION OR TRAUMA THAT COULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT'S VNS WAS DISABLED. VNS REVISION SURGERY IS POSSIBLE, BUT THE PATIENT'S FAMILY WOULD LIKE TO POSTPONE SURGICAL INTERVENTION FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 10789

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR