BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 2191592 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01642
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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 THROUGH AN IMPLANT CARD RECEIVED BY THE MFR THAT A PT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY DUE TO LEAD DISCONTINUITY. FURTHER INFO WAS RECEIVED FROM A CO REP INDICATING THAT ADD'L INFO WILL NOT BE PROVIDED BY THE EXPLANTING HOSPITAL. THE GENERATOR WAS COMPLETELY DEAD AND THE OLD IMPLANT WAS DONE IN (B)(6) FROM WHERE THE CO REP COULD NOT OBTAIN ANY INFO. MOREOVER, THE CO REP INDICATED THE NEUROSURGEON IS RETIRED AND THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR