BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 302

    MDR report key: 789429 · Received November 21, 2006

    Report

    Report Number
    1644487-2006-00436
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Date of Event
    January 1, 2006
    Report Date
    October 25, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    p970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H.6.: REVIEW OF X-RAYS BY MANUFACTURER DID NOT REVEAL ANY OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. H.6.: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SYSTEMS DIAGNOSTICS TESTING AT OFFICE VISIT RESULTED IN HIGH LEAD IMPEDANCE READINGS, INDICATING A POSSIBLE LEAD BREAK. PATIENT IS ASYMPTOMATIC. NO SERIOUS INJURY WAS REPORTED. REVIEW OF X-RAYS BY REPORTER AND MANUFACTURER DID NOT REVEAL ANY OBVIOUS LEAD BREAKS. REVISION SURGERY IS BEING DISCUSSED, BUT NO SURGERY DATE HAS BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 302 LYJ LYJ CYBERONICS, INC. 302-20 6822

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR