BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2910954 · Received January 11, 2013

    Report

    Report Number
    1644487-2013-00116
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 12, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE HAS REQUESTED TO ATTEND THE PATIENT'S NEXT APPOINTMENT. THE PHYSICIAN REPORTED TO THE COMPANY REPRESENTATIVE THAT HE WAS ABLE TO USE THE VNS PROGRAMMING SYSTEM WITH OTHER PATIENT'S ON THE SAME DAY AS THE EVENT, AND HE HAS NOT HAD ANY PROBLEMS WITH THE SYSTEM SINCE.

    Description of Event or Problem · 1

    A COPY OF THE PHYSICIAN'S FLASHCARD WAS RECEIVED BUT DID NOT INCLUDE ANY PROGRAMMING/DIAGNOSTIC HISTORY FOR THE PATIENT'S DEVICE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 REPORTED THAT THERE WAS CONCERN THAT THE PATIENT'S VNS MAY NOT BE WORKING. HOWEVER OF NOTE, THE PATIENT HAD NOT HAD A SEIZURE FOR SOME TIME. THE GENERATOR WAS INTERROGATED SUCCESSFULLY, AND NO CHANGES WERE MADE TO THE SETTINGS. THE TREATING NEUROLOGIST INDICATED IN THE NOTES THAT ALTHOUGH THE END OF SERVICE INDICATOR SAID NO, THE "INTERACTION WITH THE DEVICE ITSELF WAS SPORADIC AND IT SEEMED TO INTERACT WITH THE INTERROGATING DEVICE SPORADICALLY, INDICATING A LOW BATTERY." THE PHYSICIAN REPORTEDLY TRIED SWIPING THE MAGNET AND ON REVIEW OF THE MAGNET SWIPES, BUT THEY DID NOT SEEM TO REGISTER. THE PHYSICIAN NOTED THAT THE INTERACTION WITH THE DEVICE SUGGESTS THE BATTERY WAS LOW, ALTHOUGH THE END OF SERVICE WAS INDICATED AS NO ON THE DEVICE. FOLLOW-UP WITH THE PHYSICIAN REVEALED THAT THREE OTHER PATIENTS' DEVICES WERE INTERROGATED THE SAME DAY AND DID NOT HAVE THE SAME ISSUE WITH SPORADIC COMMUNICATION. THEREFORE, THE PROGRAMMING SYSTEM WAS FUNCTIONING PROPERLY. THE PHYSICIAN REPORTED THAT THERE WERE NO NEARBY SOURCES OF EMI THAT MAY HAVE CAUSED INTERMITTENT COMMUNICATION. PER THE PHYSICIAN, THE PATIENT WAS WEARING THE VNS MAGNET ON THE WRIST AND SWIPED IT ACCIDENTALLY AT LEAST THREE TIMES DURING THE APPOINTMENT PRIOR TO EXAMINING THE DEVICE. THE PHYSICIAN INTERROGATED, SWIPED THE MAGNET, THEN WAITED AS RECOMMENDED IN LABELING, AND INTERROGATED THE DEVICE AGAIN WITHOUT IT REGISTERING ON THE MAGNET SWIPE LIST ON THE HANDHELD COMPUTER. ATTEMPTS FOR A COPY OF THE PHYSICIAN'S FLASHCARD TO ASSESS THE MAGNET HISTORY/DIAGNOSTICS AND FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17688 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102 017152

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR