BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4133530 · Received October 1, 2014

    Report

    Report Number
    1644487-2014-02533
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    ANALYSIS OF THE USB CABLE WAS COMPLETED ON 10/15/2014. THE CAUSE FOR THE REPORTED ALLEGATION IS ASSOCIATED WITH A DISCONNECTED WIRE CONNECTION IN THE RETURNED SERIAL CABLE. SEM ANALYSIS OF THE WIRE STRANDS IDENTIFIED THAT A STRESS-INDUCED FRACTURE HAD OCCURRED. ONCE THE WIRE WAS SOLDERED ONTO THE SERIAL CABLE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING TABLET IS GIVING AN ERROR MESSAGE "CANNOT OPEN PORT" DURING DEVICE INTERROGATION. IT WAS REPORTED THAT TROUBLESHOOTING WAS PERFORMED BY DISCONNECTING THE USB CABLE FOR 15 SECONDS AND THEN REINSERTING IT AND LETTING IT SIT FOR 15 SECONDS AND THEN DEVICE INTERROGATION WAS RETRIED. THE ERROR MESSAGE WAS RECEIVED AGAIN AND THERE WAS NOT ANOTHER TABLET AVAILABLE TO TEST THE USB CABLE. THE PHYSICIAN WAS PROVIDED A NEW USB CABLE. THE NON-FUNCTIONING USB CABLE WAS RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612358 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1