BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2945179 · Received February 6, 2013

    Report

    Report Number
    1644487-2013-00303
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE CAUSED EVENT BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.TYPE OF DEVICE NAME, CORRECTED DATA: INITIAL MDR INCORRECTLY LISTED WRONG DEVICE NAME.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING SYSTEM WAS UNABLE TO INTERROGATE A DEMO GENERATOR. A DIFFERENT PROGRAMMING SYSTEM WAS USED TO SUCCESSFULLY INTERROGATE THE DEMO GENERATOR CONFIRMING IT WAS NOT AT END OF SERVICE. THE WAND BATTERY WAS CHECKED AND FOUND TO BE FINE. FURTHER TROUBLESHOOTING WAS PERFORMED TO DETERMINE WHICH PART OF THE PROGRAMMING SYSTEM WAS CAUSING THE ISSUE, AND IT WAS DETERMINED THAT THE CAUSE OF THIS ISSUE WAS THE SERIAL CABLE. THE SERIAL CABLE WAS RETURNED ON (B)(4) 2013 AND IS PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS PERFORMED ON THE RETURNED SERIAL CABLE AND THE REPORTED COMPLAINT WAS IDENTIFIED. DURING TESTING IT WAS IDENTIFIED THAT THE SERIAL CABLE WAS UNABLE TO ESTABLISH COMMUNICATION USING A KNOWN GOOD WAND AND HANDHELD. THE CAUSE FOR THE COMMUNICATION DIFFICULTIES IS ASSOCIATED WITH A BROKEN WIRE CONNECTION ON THE AXIM CONNECTOR PLUG PCB. ONCE THE WIRE WAS SOLDERED BACK ONTO THE DELL AXIM CONNECTOR PLUG PCB, THE SERIAL CABLE WAS ABLE TO ESTABLISH COMMUNICATION BETWEEN THE HHD AND WAND. THE MOST LIKELY CAUSE FOR THE WIRE BREAK CAN BE ASSOCIATED WITH MISHANDLING OF THE SERIAL CABLE. NO FURTHER ANOMALIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49811 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073772

    Patients

    Seq Age Sex Outcome Treatment
    1