BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4243373 · Received November 11, 2014

    Report

    Report Number
    1644487-2014-02985
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN LOW IMPEDANCE (<600 OHMS). THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS REFERRED FOR X-RAYS. NO PATIENT MANIPULATION OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE LOW IMPEDANCE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725135 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 2746

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR