BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4027389 · Received August 21, 2014

    Report

    Report Number
    1644487-2014-02047
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 19, 2014
    Report Date
    July 23, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS INTERROGATED AND FOUND TO BE AT 0MA. IT WAS REPORTED THAT THE PATIENT WAS NOT INTENTIONALLY PROGRAMMED TO 0MA. MULTIPLE SYSTEM DIAGNOSTICS WERE PERFORMED WHICH SHOWED LEAD IMPEDANCE - OK AND OUTPUT CURRENT - LOW. IT WAS REPORTED THAT THE GENERATOR WAS PROGRAMMED BACK ON SUCCESSFULLY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING ON THE. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE END OF THE RETURNED LEAD PORTIONS. INCISIONS IN THE SILICONE TUBING OF THE LEAD WERE NECESSARY TO PERFORM PROPER INSPECTION. ABRADED OPENINGS WERE NOTED ON THE OUTER TUBING AND A CUT OPENING WAS NOTED IN OUTER TUBING AT THE LEAD BODY. A COIL DISCONTINUITY WAS IDENTIFIED IN THE NEGATIVE COIL IN THE VICINITY OF THE AREA WHERE A SUSPECTED BREAK WAS NOTED. VISUAL EXAMINATION OF THE LEAD AND COIL AT THIS LOCATION SHOW THAT THE COIL WAS CUT. THE TIME AT WHICH THE CUT OCCURRED CANNOT BE DETERMINED. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505298 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201958

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR