BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1840043 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02102
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT WAS REFERRED FOR PROPHYLACTIC GENERATOR REVISION AND LEAD REPLACEMENT DUE TO FRACTURE. A SEARCH PERFORMED IN THE MFR'S PROGRAMMING HISTORY DATABASE SHOWED THAT LAST DIAGNOSTICS PERFORMED ON (B)(6) 2009 WERE WITHIN NORMAL LIMITS. THE PT'S EXPLANTED PULSE GENERATOR AND LEAD WERE RETURNED TO THE MFR FOR ANALYSIS, WHICH HAVE YET TO BE COMPLETED. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 2656

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR