BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2092179 · Received April 27, 2011

    Report

    Report Number
    1644487-2011-00888
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    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

    A VNS PHYSICIAN REPORTED THAT A PT HAD HIGH IMPEDANCE AFTER RECENTLY UNDERGOING A BATTERY REPLACEMENT. THERE WAS NO REPORTED CAUSAL ISSUE SINCE THE IMPLANT, AND THE PT'S DEVICE WAS IMMEDIATELY DISABLED. THE DIAGNOSTIC HISTORY FROM THE PT'S REPLACEMENT SURGERY WAS REVIEWED BY A COMPANY REP, AND IT WAS CONFIRMED THAT ALL DIAGNOSTICS PERFORMED THERE WERE WITHIN NORMAL LIMITS WITH IMPEDANCE IN THE 3900 OHMS RANGE. A REVISION SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1285

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR