BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4211685 · Received October 29, 2014

    Report

    Report Number
    1644487-2014-02884
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT'S DEVICE IS SHOWING HIGH IMPEDANCE AND BATTERY DEPLETION. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT REQUIRES LEAD AND GENERATOR REVISION DUE TO HIGH IMPEDANCE. NO KNOWN SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT BOTH GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2014. ATTEMPTS WERE MADE FOR THE EXPLANTED PRODUCTS BUT THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692545 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1257

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR