BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3926496 · Received July 10, 2014

    Report

    Report Number
    1644487-2014-01749
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SERIAL ADAPTER CORD WAS RECEIVED BY THE MANUFACTURER FOR ANALYSIS. HOWEVER, ANALYSIS HAS NOT COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE SERIAL CABLE ADAPTER WAS COMPLETED, AND THE REPORTED ALLEGATION WAS VERIFIED. THE CAUSE FOR THE REPORTED ALLEGATION IS ASSOCIATED WITH AN OPEN WIRE CONNECTION IN THE RETURNED SERIAL CABLE WHICH APPEARS TO BE CABLE STRESS-RELATED. NO FURTHER ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING TABLET WAS GIVING THE MESSAGE "UNABLE TO OPEN THE PORT. THE SYSTEM CANNOT FIND THE FILE SPECIFIED." THE SERIAL ADAPTER CORD WAS DISCONNECTED AND INTERROGATION WAS ATTEMPTED AGAIN ON THE PATIENT'S DEVICE AND THE SAME MESSAGE WAS RECEIVED. ANOTHER SERIAL ADAPTER CORD WAS NOT AVAILABLE; HOWEVER, THE PATIENT WAS ABLE TO BE INTERROGATED SUCCESSFULLY USING ANOTHER PROGRAMMING DEVICE. THE TABLET WAS RECEIVED FOR ANALYSIS. ANALYSIS OF THE TABLET WAS COMPLETED ON (B)(4) 2014. THE TABLET WAS RECEIVED WITHOUT A SERIAL ADAPTER CORD. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH THE TABLET PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE TABLET PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE SERIAL ADAPTER CORD IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404758 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1