BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3172888 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01803
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    August 28, 2006
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    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

    ON (B)(6) 2013 DURING REVIEW OF THE PATIENT¿S PROGRAMMING HISTORY IT WAS OBSERVED THAT ON AUGUST 28, 2006 HIGH IMPEDANCE WAS OBSERVED. THE PATIENT¿S GENERATOR WAS DISABLED THAT SAME DAY. THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2006. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273364 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1049

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR