BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 800244 · Received December 14, 2006

    Report

    Report Number
    1644487-2006-00452
    Event Type
    Malfunction
    Date Received
    December 14, 2006
    Report Date
    August 28, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    p970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAYS REVIEWED IN THE SURGEON'S OFFICE WITH CYBERONICS, INC. REP. LEAD BREAK VISUALIZED. DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED AN IMPLANT CARD ON 11/28/2006 REPORTING THAT THE PT'S GENERATOR AND LEAD WERE REIMPLANTED DUE TO A LEAD DISCONTINUITY. FURTHER INVESTIGATION REVEALED THAT A FINDING OF HIGH LEAD IMPEDANCE WAS OBSERVED IN 2006 BY THE TREATING PHYSICIAN AND THE CYBERONICS, INC. REP. PT WAS REFERRED TO HIS SURGEON BY THE TREATING PHYSICIAN. A LEAD FRACTURE WAS CONFIRMED AFTER 33 DAYS LATER BY X-RAYS READ BY THE SURGEON AND THE CYPERONICS, INC. REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYZ MUZ CYBERONICS, INC. 300-20 011406

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR