BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3222787 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02088
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 INDICATING THAT THIS PATIENT¿S VNS DEVICE WAS MALFUNCTIONING. IT WAS NOTED THAT THE DESIRED OUTPUT CURRENT WAS 3.50 MA BUT THE RECEIVED OUTPUT CURRENT WAS 2.0 MA. A SECOND PAGE OF CLINIC NOTES FROM THE SAME DATE INDICATED THAT ALL PARAMETERS DURING SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE DIAGNOSTICS SHOWED THAT THE DEVICE WAS FUNCTIONING NORMALLY. THE PATIENT IS IMPLANTED WITH A MODEL 102 GENERATOR. THIS DEVICE WOULD NOT DISPLAY THE PARAMETERS THAT THE PHYSICIAN USED TO DETERMINE THAT THE DEVICE WAS MALFUNCTIONING. ATTEMPTS TO CLARIFY WHY THE DEVICE WAS SAID TO BE MALFUNCTIONING HAVE BEEN UNSUCCESSFUL. THE PATIENT WAS REFERRED FOR REVISION. THE PATIENT¿S LAST SEIZURE WAS NOTED TO BE ON (B)(6) 2013. THE PATIENT WAS PREVIOUSLY SEEN ON (B)(6) 20123 AT WHICH TIME THE LAST SEIZURE WAS NOTED TO BE ON (B)(6) 2013. AT ONE POINT, THE PATIENT WAS SEIZURE FREE BUT RELAPSED. A SYSTEM DIAGNOSTIC ON (B)(6) 2013 WAS WITHIN NORMAL LIMITS, AND SETTINGS WERE ADJUSTED ON THIS DATE. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THIS VNS PATIENT UNDERWENT REVISION SURGERY. THE DEVICE IS NOT EXPECTED FOR RETURN AS IT WAS DISCARDED. REVIEW OF ADDITIONAL PROGRAMMING HISTORY SHOWED DIAGNOSTIC HISTORY WITHIN NORMAL LIMITS INDICATING THAT THE DEVICE WAS PERFORMING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324176 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014277

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR