BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2230927 · Received September 1, 2011

    Report

    Report Number
    1644487-2011-02039
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE VNS TREATING PHYSICIAN REPORTED THAT THE VNS PATIENT WAS SEEN EARLIER THAT DAY AND SHE COULDN'T INTERROGATE THE DEVICE. THE PHYSICIAN SAID THAT THIS PATIENT IS HER ONLY VNS PATIENT AND WAS LAST INTERROGATED ON (B)(6) 2011. THE PHYSICIAN REPORTED THAT HER HANDHELD WAS PLUGGED INTO THE WALL, WHICH COULD CAUSE ELECTROMAGNETIC INTERFERENCE. THE WAND BATTERY LIGHT WAS CHECKED AND ONLY STAYED ON FOR ABOUT 20 SECONDS, SO THE BATTERY MAY HAVE BEEN LOW. THE PHYSICIAN WASN'T SURE IF THE PATIENT'S DEVICE WAS AT EOS. THE PATIENT'S LAST SETTINGS WERE AT OUTPUT=0.75MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=3.0MIN. THE PHYSICIAN STATED THAT THE PATIENT IS STILL ABLE TO FEEL THE STIMULATION AND THERE HASN'T BEEN ANY CHANGE IN HER DEPRESSION OTHER THAN HER NORMAL FLUCTUATIONS. THE PHYSICIAN SAID THAT THE PATIENT IS SCHEDULED TO BE SEEN IN ANOTHER 6 WEEKS, BUT MAY BE ABLE TO GET HER IN EARLIER. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH REVEALED 5.27 YEARS REMAINING UNTIL ERI =YES. THE REGIONAL AREA MANAGER VISITED THE PHYSICIAN TO TROUBLESHOOT HER PROGRAMMING SYSTEM. THE PROGRAMMING SYSTEM WORKED FINE WITH THE DEMO GENERATOR AND HAD NO PROBLEMS. THE PHYSICIAN REPORTED THAT SHE BELIEVES THE PROBLEM WAS THAT SHE LIKELY HAD HER HANDHELD PLUGGED INTO THE WALL ON THE PATIENT¿S VISIT THAT CAUSED HER NOT TO BE ABLE TO INTERROGATE THE DEVICE. THE DATE OF THE PATIENT¿S NEXT APPOINTMENT HAS BEEN REQUESTED FROM THE PHYSICIAN TO CONFIRM THAT THE PATIENT¿S GENERATOR CAN BE INTERROGATED AND THE PROBLEM WAS ELECTROMAGNETIC INTERFERENCE FROM THE HANDHELD BEING PLUGGED INTO THE WALL, BUT THAT INFORMATION HAS NOT BEEN RECEIVED FROM THE PHYSICIAN TO DATE. IF FURTHER INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6), 2011 ADDITIONAL INFORMATION WAS RECEIVED WHEN THE PHYSICIAN REPORTED THAT SHE THINKS THE PROBLEM WAS THAT HER PROGRAMMING SYSTEM WAS PLUGGED INTO THE WALL, THEREBY CAUSING ELECTROMAGNETIC INTERFERENCE. THE PATIENT IS DOING FINE AND HAS NO COMPLAINTS. THE PATIENT DOES NOT WANT TO COME IN FOR ANOTHER CLINICAL VISIT UNTIL HER APPOINTMENT ON (B)(6), 2011. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS INC 102 013118

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR