BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 303

    MDR report key: 2950681 · Received February 8, 2013

    Report

    Report Number
    1644487-2013-00345
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 5, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS VNS PATIENT WOULD BE UNDERGOING FULL REVISION FOR AN UNKNOWN REASON. ON (B)(6) 2013, IT WAS STATED THAT THE PATIENT'S GENERATOR WAS REPLACED PROPHYLACTICALLY, BUT THE PATIENT'S LEAD WAS REPLACED DUE TO HIGH IMPEDANCE. HIGH IMPEDANCE DURING DIAGNOSTICS AS SEEN PRIOR TO REVISION, AND IT WAS UNKNOWN IF THE DEVICE WAS PROGRAMMED OFF AFTER HIGH IMPEDANCE WAS SEEN. X-RAYS HAD NOT BEEN TAKEN AND THERE WAS NO KNOWN PATIENT MANIPULATION OR TRAUMA. ADDITIONAL FOLLOW-UP SHOWED THAT THE PATIENT WAS SEEN ON (B)(6) 2012 BECAUSE HE STATED THAT HIS DEVICE WAS NOT WORKING: THE PATIENT WAS NO LONGER FEELING STIMULATION, AND HIGH IMPEDANCE WAS SEEN. THERE WAS NO RECENT MANIPULATION OR TRAUMA. THE EXPLANTING FACILITY DOES NOT RETURN EXPLANTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54437 LEAD MODEL 303 LEAD LYJ CYBERONICS INC 303-20 2786

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR