BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3812355 · Received May 15, 2014

    Report

    Report Number
    1644487-2014-01275
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE HANDHELD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE HANDHELD ANALYSIS WAS COMPLETED ON (B(4) 2014. NO ANOMALIES ASSOCIATED WITH THE BATTERY LATCH WERE IDENTIFIED. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE MAIN BATTERY WAS SWOLLEN. THE SWOLLEN BATTERY BENT THE BATTERY COVER CAUSING THE BATTERY LATCH SWITCH TO REGISTER THAT THE LATCH WAS UNLOCKED, THUS CAUSING THE HANDHELD TO POWER OFF. NO FURTHER 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

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WAS HARD TO POWER ON AFTER BEING CHARGED. ONCE THE HANDHELD POWERED ON AN INTERROGATION WAS ATTEMPTED AT WHICH TIME THE HANDHELD POWERED OFF. UPON RESTARTING THE HANDHELD AN ERROR MESSAGE WAS OBTAINED INDICATING THAT THE BATTERY DOOR LATCH WAS OPEN. TROUBLESHOOTING CONFIRMED THAT THE LATCH WAS CLOSED; HOWEVER, IT WAS NOTED THAT THE DOOR APPEARED TO BE BOWED. THE BATTERY WAS CONFIRMED TO BE NORMAL IN SIZE AND THE HANDHELD WAS STORED AT NORMAL RECOMMENDED TEMPERATURES. THE BATTERY CONFIRMED TO BE AT 100% AND AGAIN SHUT DOWN WITH THE SAME ERROR MESSAGE BEING RECEIVED UPON RESTARTING A SECOND TIME. A NEW PROGRAMMING COMPUTER WAS PROVIDED TO THE PHYSICIAN AND THE HANDHELD AND FLASHCARD WERE RETURNED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291959 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1