BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1891025 · Received October 29, 2010

    Report

    Report Number
    1644487-2010-02433
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CONCLUSIONS: DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS BEING REFERRED FOR BATTERY REVISION DUE TO UNKNOWN REASONS. LATER, IT WAS INDICATED THAT THE PT'S BATTERY WAS UNABLE TO BE INTERROGATED AS IT WAS BELIEVED TO BE DEPLETED. WHEN THE NEW GENERATOR WAS CONNECTED TO THE EXISTING LEADS, DIAGNOSTICS PERFORMED RESULTED IN HIGH LEAD IMPEDANCE. TROUBLESHOOTING PERFORMED WITH THE NEW GENERATOR AND EXISTING LEADS DID NOT RESOLVE THE ISSUE, SO THE LEADS WERE REPLACED AT THAT TIME. SUBSEQUENT DIAGNOSTICS PERFORMED WERE WITHIN NORMAL LIMITS. THE EXPLANTED PULSE GENERATOR AND LEAD PORTIONS WERE RETURNED TO THE MFR FOR ANALYSIS, BUT HAVE YET TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009441

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR