BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2983652 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00558
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: WITH THE NEW INFORMATION, THE PATIENT'S AGE AT THE TIME OF EVENT WAS INADVERTENTLY REPORTED INCORRECTLY ON THE INITIAL REPORT. DATE OF EVENT, CORRECTED DATA: WITH THE NEW INFORMATION, THE DATE OF EVENT WAS INADVERTENTLY REPORTED INCORRECTLY ON THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: THE SUPPLEMENTAL REPORT #1 INADVERTENTLY CHANGED THE AGE INCORRECTLY AS THE EVENT DATE SHOULD REMAIN AS (B)(6). DATE OF EVENT, CORRECTED DATA: THE SUPPLEMENTAL REPORT #1 INADVERTENTLY CHANGED THE EVENT DATE INCORRECTLY, AND THE EVENT HAS NOW BEEN CONFIRMED INVALID. THE SETTINGS FOUND ON (B)(6) 2013 WERE INTENTIONALLY PROGRAMMED IN 2011. REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    THE NURSE LATER REPORTED ON (B)(6) 2013 THAT SHE "DOESN'T THINK THEY ARE OVERLY CONCERNED WITH THE PROGRAMMED PARAMETERS AS THERE ARE A COUPLE OF OTHER INDIVIDUALS WHO DO THE PROGRAMMING) AND SHE SUSPECTS THAT WHEN SOMEBODY ELSE WAS DOING THE PROGRAMMING, THEY INADVERTENTLY PROGRAMMED THE SETTINGS AND FORGOT TO DOCUMENT IT OR DID NOT REALIZE THEY HAD CHANGED THEM SO WHEN THEY WENT BACK TO INTERROGATE, THE NURSE DID NOT REALIZE THE CHANGES HAD BEEN MADE. IT LOOKS LIKE THEY WERE MADE SOMEWHERE CLOSE TO A YEAR AGO. THE PATIENT HAS BEEN DOING WELL. THERE ARE NO REAL PROBLEMS WITH THE SETTINGS THAT WERE FOUND. SHE REPORTS THAT IT WAS "NOTHING TOO ALARMING". THE REPORTING NURSE PERFORMS THE MAJORITY OF THE PATIENT'S PROGRAMMING. THE COMPANY REPRESENTATIVE COPIED THE HANDHELD FLASHCARDS AND MAILED THEM BACK TO RETURN TO THE MANUFACTURER, BUT THE PROGRAMMING HISTORY HAS NOT BEEN REVIEWED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 REPORTED THAT THE VNS PROGRAMMING FREQUENCY AND PULSE WIDTH APPEARED TO BE AT UNINTENDED SETTINGS PER THE NURSE PRACTITIONER BUT THE REASON IS UNCLEAR. "PATIENT'S VNS WAS INTERROGATED - THE FREQUENCY NOTED IN CHART AT LAST VISIT SHOWED 20 HZ AND PULSE WIDTH 250USEC. MOM DENIES HAVING HAD VNS PROGRAMMED DURING HOSPITAL ADMISSIONS OR BY ANOTHER NEUROLOGIST. " ATTEMPTS FOR A COPY OF THE NURSE'S FLASHCARD ARE UNDERWAY, BUT UPDATED PROGRAMMING HISTORY HAS NOT BEEN REVIEWED TO DATE. THE LAST KNOWN PROGRAMMING SETTINGS IN THE IN-HOUSE MANUFACTURER'S DATABASE ARE THE SAME SETTINGS AS THE "REVIEW OF PREVIOUSLY PROGRAMMED PARAMETERS" THAT WERE PROVIDED IN THE CLINIC NOTES.

    Description of Event or Problem · 1

    THE LAST KNOWN PROGRAMMING SETTINGS IN THE IN-HOUSE MANUFACTURER'S DATABASE ARE THE SAME SETTINGS AS THE "REVIEW OF PREVIOUSLY PROGRAMMED PARAMETERS" THAT WERE PROVIDED IN THE CLINIC NOTES. BASED ON THE SEQUENCE OF EVENTS OUTLINED IN THE VNS PROGRAMING HISTORY DATABASE, IT APPEARS THAT THE DEVICE WAS PROGRAMMED TO 30HZ/500USEC SINCE BEING PROGRAMMED TO THOSE SETTINGS ON (B)(6) 2011 WITH THE SAME PROGRAMMING SYSTEM. THEREFORE, IT APPEARS THAT NO DEVICE MALFUNCTION OCCURRED AND THE DEVICE WAS INTENTIONALLY PROGRAMMED TO THESE SETTINGS. THE SETTINGS MENTIONED IN THE NOTES DATED (B)(6) 2013 WERE INTENTIONALLY PROGRAMMED ON (B)(6) 2011, AND THE FREQUENCY AND PULSE WIDTH WERE INTENTIONALLY CHANGED FROM 20HZ/250USEC ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87589 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 201039

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR