BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 3182149 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01878
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING HISTORY RECORDS PERFORMED. REVIEW OF GENERATOR MANUFACTURING HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE MANUFACTURER¿S DISTRIBUTOR REPORTED THAT THE PATIENT HAS HAD THE VNS DISABLED FOR OVER A YEAR AND MAYBE EVEN LONGER. THE PATIENT WAS BROUGHT INTO THE CLINIC TO HAVE HER DEVICE TURNED ON TO TEST THE VNS SYSTEM PRIOR TO HAVING AN MRI. THE DEVICE WAS PREVIOUSLY DISABLED FOR A LONG TIME ON AN UNKNOWN DATE. THE MEDICAL PROFESSIONAL WAS CONSIDERING TITRATING THE DEVICE UP BASED ON THE PATIENT¿S COMFORT LEVEL. HOWEVER, IT WAS LATER REPORTED THAT THE DISTRIBUTOR WAS UNABLE TO INTERROGATE THE DEVICE, ¿AS EXPECTED¿ WITH THE PROGRAMMING SYSTEM AND DIAGNOSTIC TESTING COULD NOT BE PERFORMED. ATTEMPTS FOR ADDITIONAL INFORMATION AND CLARIFICATION HAVE BEEN UNSUCCESSFUL TO DATE. THE DEVICE HAS BEEN IMPLANTED SINCE 2000, SO BASED ON THE PATIENT¿S SETTINGS AND DEPENDING ON HOW LONG THE DEVICE WAS TURNED OFF, THE DEVICE MAY BE AT END OF SERVICE WHICH MAY HAVE ATTRIBUTED TO THE FAILURE TO INTERROGATE THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR COULD NOT BE COMMUNICATED WITH ON (B)(6) 2013. NO EMI WAS PRESENT THAT IS BELIEVED TO HAVE CONTRIBUTED TO THE FAILURE TO COMMUNICATE WITH THE DEVICE. THE PROGRAMMING WAND BATTERY WAS CONFIRMED TO HAVE ADEQUATE POWER. THE COMPUTER WAS UNPLUGGED FROM THE WALL OUTLET AND FULLY CHARGED AS RECOMMENDED. TROUBLESHOOTING STEPS WERE PERFORMED AND COMMUNICATION COULD NOT BE ESTABLISHED AFTER FOUR ATTEMPTS. THE PROGRAMMING SYSTEMS USED TO TRY AND INTERROGATE THE PATIENT¿S DEVICE ARE FUNCTIONING PROPERLY AND HAVE BEEN USED SUCCESSFULLY ON OTHER PATIENTS AFTER THE EVENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE, AS THE NURSE WAS UNABLE TO PROVIDE FURTHER DETAILS INCLUDING PROGRAMMING/DIAGNOSTIC HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282827 PULSE GEN MODEL 100 GENERATOR LYJ CYBERONICS, INC. 100C 31146C

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR