BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING COMPUTER

    MDR report key: 3800223 · Received May 8, 2014

    Report

    Report Number
    1644487-2014-01221
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WILL NOT POWER ON AND THE CHARGE LIGHT DOES NOT ILLUMINATE WHEN THE UNIT IS PLUGGED INTO THE AC POWER CORD. A KNOWN WORKING POWER CORD WAS USED AND THE CHARGE LIGHT WOULD STILL NOT ILLUMINATE AND THE HANDHELD WOULD NOT POWER ON. THE LOCK BUTTON WAS NOT ENGAGED. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING TABLET AND THE HANDHELD AND FLASHCARD WERE RETURNED FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WOULD NOT POWER ON. THE CAUSE FOR THE IDENTIFIED ANOMALY IS ASSOCIATED WITH AN OPEN FUSE IN THE HANDHELD. ONCE THE FUSE WAS REPLACED NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE CAUSE FOR THE OPEN FUSE IS MOST LIKELY RELATED WITH AN ELECTRICAL SHORT CAUSED BY THE DAMAGED RECORD BUTTON ON THE SIDE OF THE HANDHELD. NO OTHER ANOMALIES WERE IDENTIFIED. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4)2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED DATED (B)(6) 2014 FOR THE PATIENT. PER THE NOTES, THE PATIENT WAS IN TO SEE THE PHYSICIAN FOR A FOLLOW UP EVALUATION FOR SEIZURES. DURING THE VISIT, THE CLINIC NOTES STATED THAT THE PATIENT'S GENERATOR WAS NOT ABLE TO BE INTERROGATED DUE TO "TECHNICAL ISSUES". THROUGH ADDITIONAL INVESTIGATION, THE PHYSICIAN CONFIRMED THAT THESE "TECHNICAL ISSUES" WERE REFERRING TO THE REPORTED EVENT OF THE HAND HELD PROGRAMMING DEVICE NOT BEING ABLE TO POWER ON, WHICH WAS REPORTED IN MFR REPORT # 1644487-2014-01221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278992 PROGRAMMING COMPUTER PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 879565

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR