BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2870471 · Received December 12, 2012

    Report

    Report Number
    1644487-2012-03309
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    September 17, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE SUICIDE ATTEMPT MAY BE A COMBINATION OF MEDICATION CHANGES, PSYCHIATRIC DISEASE, AND A DEPLETED VNS GENERATOR, BUT IS NOT SURE WHAT THE EXACT CAUSE IS. REPLACEMENT OF THE VNS IS PLANNED, BUT HAS NOT OCCURRED TO DATE. CURRENT VNS DIAGNOSTICS ARE NOT KNOWN AS THE GENERATOR CANNOT BE INTERROGATED DUE TO END OF SERVICE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 WERE RECEIVED FROM THE REPORTER TO THE MANUFACTURER INDICATING THE PATIENT "TRIED TO CUT HERSELF AND PUT HERSELF IN A COFFIN" ABOUT A MONTH PREVIOUSLY. THE PATIENT DOES HAVE A HISTORY OF SUICIDE ATTEMPTS IN ADOLESCENCE PRIOR TO THE VNS BEING IMPLANTED. REPLACEMENT OF THE VNS GENERATOR IS BEING CONSIDERED. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 38308C

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other