BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1832116 · Received September 3, 2010

    Report

    Report Number
    1644487-2010-02015
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT PRESENTED HIGH LEAD IMPEDANCE DURING A ROUTINE OFFICE VISIT. THE PT HAD ALSO EXPERIENCED AN INCREASE IN SEIZURES 6 TO 8 MONTHS PRIOR TO THE HIGH LEAD IMPEDANCE READINGS. THE DATE OF THE LAST KNOWN GOOD DIAGNOSTICS IS UNK. THE PT HAD BEEN PULLING AND HITTING THE AREA WHICH MAY HAVE CAUSED THE HIGH LEAD IMPEDANCE. THE PT'S DEVICE WAS PROGRAMMED OFF AND HE WILL NOT HAVE SURGERY AT THIS TIME. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE. A REVIEW OF THE PT'S PROGRAMMING HISTORY AND A BATTERY LIFE CALCULATION WAS PERFORMED WHICH INDICATED THAT THE DEVICE HAD SEVERAL YEARS REMAINING UNTIL ERI = YES THEREFORE, MDR 1644487-2010-02013 WILL BE SUBMITTED TO CAPTURE THE PREMATURE END OF SERVICE OF THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200444

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention