BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2954935 · Received February 11, 2013

    Report

    Report Number
    1644487-2013-00355
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    October 17, 2011
    Report Date
    January 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    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

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAS CHRONIC SUICIDE IDEATIONS THAT WORSENED BY (B)(6) 2011. THE PHYSICIAN REPORTED THAT HE BELIEVED THEY WORSENED DUE TO LOSS OF VNS THERAPY AS THE DEVICE WAS AT EOS. INTERVENTIONS TAKEN WERE THAT THE PATIENT WAS SEEN MORE FREQUENTLY AND 2 DOSES OF MEDICATION WERE CHANGED. THE PATIENT'S SUICIDE IDEATIONS "WORSENED OFF VNS." NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE SUICIDE IDEATIONS. CLINIC NOTES DATED (B)(6) 2010 WERE RECEIVED WHICH INDICATED THAT PATIENT ADMITTED TO SOME SUICIDE IDEATIONS; "WISHING I WERE DEAD." THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2012 DUE TO END OF SERVICE. THE GENERATOR WAS RETUNED FOR PRODUCT ANALYSIS. THE END OF SERVICE CONDITION WAS CONFIRMED IN THE PRODUCT ANALYSIS LAB; AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF NORMAL, EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION, THE ELECTRICAL TEST RESULTS AND THE BENCH EVALUATION. THE GENERATOR WAS UNABLE TO BE INTERROGATED AND DETERMINED TO BE THE RESULT OF NORMAL BATTERY DEPLETION. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND PRODUCT ANALYSIS CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58534 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS INC 102 015644

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other