BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3210817 · Received July 8, 2013

    Report

    Report Number
    1644487-2013-02046
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT UNDERWENT LEAD REVISION SURGERY DUE TO HIGH IMPEDANCE. THE PATIENT WAS REPORTED TO HAVE HAD GOOD DIAGNOSTICS BACK IN (B)(6) 2013. THE PHYSICIAN HAD NOT PROGRAMMED THE DEVICE OFF DESPITE THE HIGH IMPEDANCE DUE TO THE PATIENT¿S SEIZURE SEVERITY BUT HE DID REFER HER FOR A REVISION SURGERY AS SOON AS POSSIBLE. IT WAS ALSO REPORTED THAT X-RAYS WERE NOT TAKEN. NO TRAUMA OR EVENT OCCURRED THAT THE PHYSICIAN KNEW OF THAT COULD HAVE CAUSED THE HIGH IMPEDANCE. ALL DIAGNOSTICS WERE WITHIN NORMAL LIMITS AFTER THE LEAD WAS REPLACED. IT WAS REPORTED THAT THE LEAD WAS TAKEN OUT IN SECTIONS AND DESTROYED THEREFORE COULD NOT BE RETURNED FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED THAT DAY DURING DIAGNOSTICS. THE PATIENT WAS REFERRED FOR A FULL REVISION SURGERY AND X-RAYS WERE NOTED TO BE TAKEN BUT IT WAS UNCLEAR IF THEY WOULD BE SENT TO THE MANUFACTURER FOR REVIEW. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310910 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200403

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR