BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2802003 · Received October 23, 2012

    Report

    Report Number
    1644487-2012-02703
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER (MO/DAY/YR) CORRECTED DATA. SUPPLEMENTAL 02 SHOULD HAVE HAD THE DATE (B)(6) 2013 NOT 2012.

    Description of Event or Problem · 1

    A VNS PATIENT CALLED AND REPORTED THAT SHE DOESN'T FEEL LIKE THERE IS VERY MUCH KNOWLEDGE RE: VNS. SHE WANTS TO HAVE HER VNS EXPLANTED. SHE REPORTS THAT SHE HAD A MAJOR SEIZURE AND WAS KNOCKED UNCONSCIOUS WITH A CONFIRMED CONCUSSION AT HER RESIDENCE AND TAKEN TO (B)(6). SHE NOW NEEDS ASSISTANCE MOVING AROUND WHEREAS SHE DIDN'T BEFORE. PATIENT STATES WAS DIAGNOSED WITH RHABDOMYOLYSIS AND WAS CONCERNED ABOUT THE VNS CAUSING THIS. SHE WAS GOING FOR A REFERRAL FOR REMOVAL AS SHE SIMPLY HAS HAD MANY QUESTIONS ABOUT VNS AND SOME OF THE EVENTS SHE IS EXPERIENCING AND HAS NOT HAD ADEQUATE ANSWERS AND THIS IS ONE WAY SHE IS ABLE TO ASK THE QUESTIONS. SHE STATES SHE DOES RECEIVE EFFICACY FROM VNS HOWEVER, SHE DOESN'T KNOW WHAT HAPPENED WITH VNS WHEN SHE HAD HER SEIZURES AND GOT A CONCUSSION. THE PATIENT STATES THIS HAPPENED, "SAME TIME LAST YEAR". THE PATIENT REPORTS SHE WILL OCCASIONALLY HAVE SEIZURES HOWEVER, NONE REQUIRING HOSPITALIZATION. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER INFORMATION ABOUT THE REPORTED EVENTS. THUS FAR NO FURTHER INFORMATION HAS BEEN ATTAINED.

    Description of Event or Problem · 1

    GOOD FAITH ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN ATTAINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A SURGICAL CONSULT AND SHE WAS TOLD THAT HER VNS DOES NOT NEED TO BE REPLACED. THEREFORE NO INTERVENTIONS ARE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010275

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R