BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2081400 · Received April 22, 2011

    Report

    Report Number
    1644487-2011-00879
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 HIGH IMPEDANCE WAS OBTAINED ON DIAGNOSTICS OF THE PATIENT'S DEVICE ON (B)(6) 2011 AND THE DEVICE WAS DISABLED ON THAT DATE. PER REPORTER, THERE WAS GOOD DIAGNOSTICS ABOUT 10 MONTHS PRIOR, BUT THERE WAS NO DETAILS NOTED ABOUT THE RESULTS, AND THE PATIENT HAD NOT BEEN SEEN SINCE THAT APPOINTMENT 10 MONTHS AGO. THE PATIENT DID NOT REPORT ANY TRAUMA AND THE PHYSICIAN CONFIRMED THAT THERE WAS NO OTHER KNOWN CONTRIBUTORY CAUSE OF THE HIGH IMPEDANCE. IT WAS REPORTED THAT THE PATIENT HAS DECIDED NOT TO PROCEED WITH REVISION SURGERY AND NO FURTHER INTERVENTIONS ARE PLANNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1269

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR