BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1944046 · Received December 29, 2010

    Report

    Report Number
    1644487-2010-02921
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PT HAD BEEN HAVING BREAK THROUGH SEIZURES AND THE NEUROLOGIST BELIEVED THE PT'S GENERATOR WAS AT END OF SERVICE BECAUSE HE WAS UNABLE TO INTERROGATE WITH THE PT'S VNS. THE NEUROLOGIST REPORTED THAT HE WAS ABLE TO INTERROGATE OTHER PTS. THE PT WAS REFERRED TO A SURGEON FOR REPLACEMENT, HOWEVER, THE SURGEON FOUND THAT THE GENERATOR WAS NOT AT END OF SERVICE AND WAS ABLE TO INTERROGATE AND PERFORM DIAGNOSTICS ON THE VNS. THE NEUROLOGIST REPORTED THAT THE PT HAD NOT HAD ANY SEIZURES TWO MONTHS PRIOR TO AN OFFICE VISIT ON (B)(6) 2010. NO MEDICATION CHANGES, PROGRAMMING CHANGES, OR OTHER EXTERNAL FACTORS ARE BELIEVED TO HAVE CONTRIBUTED TO THE SEIZURES, HOWEVER, THE PT HAS A HISTORY OF ANXIETY. THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO PRE-VNS SEIZURE LEVELS IS NOT KNOWN. THE CAUSE OF THE INCREASE IN SEIZURES IS NOT KNOWN. NO INTERVENTIONS ARE PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015227

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention