BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3023612 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00832
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    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 TRIED TO USE THE VNS PROGRAMMING COMPUTER BUT WAS UNABLE TO DUE TO THE COMPUTER GIVING HER A WARNING MESSAGE THAT THE BATTERY LATCH IS OPEN. TROUBLE SHOOTING WAS PERFORMED TO MAKE SURE THAT THE BATTERY LATCH IS SECURED BUT THE SAME WARNING MESSAGE APPEARS. THE PRODUCT WAS SENT BACK TO THE MANUFACTURER AND WAS RECEIVED ON (B)(4) 2013 AND NOW PRODUCT ANALYSIS IS BEING PERFORMED.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS PERFORMED ON THE RETURNED PROGRAMMING COMPUTER. DURING ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WOULD POWER OFF UNEXPECTEDLY. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH A LOOSE MOUNTING SCREW ON THE BATTERY LATCH ASSEMBLY. ONCE THE SCREW WAS TIGHTENED, NO FURTHER ANOMALIES WERE IDENTIFIED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126693 PROGRAMMING SOFTWARE COMPUTER LYJ CYBERONICS, INC. MODEL 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1