BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1030358 · Received April 16, 2008

    Report

    Report Number
    1644487-2008-00859
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 21, 2008
    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

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT HAD A "BROKEN LEAD = SHORT CAUSING LOE AND LEFT CHEST WALL PAIN. WAS SENT TO SURGEON TO REPAIR IT." PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT. THREE GOOD FAITH ATTEMPTS WERE MADE WITH THIS PHYSICIAN TO OBTAIN FURTHER INFORMATION. NO FURTHER INFORMATION HAS BEEN RECEIVED. EXPLANTED LEADS WERE DISCARDED BY HOSPITAL THEREFORE PRODUCT ANALYSIS CANNOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009894

    Patients

    Seq Age Sex Outcome Treatment
    1