BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4123433 · Received September 26, 2014

    Report

    Report Number
    1644487-2014-02498
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SERIAL CABLE WAS RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE SERIAL CABLE WAS COMPLETED ON 11/17/2014. THE CAUSE FOR THE REPORTED ALLEGATION IS ASSOCIATED WITH THE SERIAL CABLE BEING PULLED OUT OF ITS STRAIN RELIEF. THE CAUSE FOR THE DAMAGED CABLE IS MOST LIKELY ASSOCIATED WITH MISHANDLING OF THE DEVICE. ALTHOUGH THE SERIAL CABLE WAS PULLED OUT OF ITS STRAIN RELIEF, NO ANOMALIES ASSOCIATED WITH THE CABLE PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. THE PHYSICIAN REPORTED THAT NO PATIENT'S WERE AFFECTED AND THAT THE NEW SERIAL CABLE RESOLVED THE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN¿S SERIAL CABLE FOR HIS HANDHELD DEVICE WAS FRAYED AND WAS NOT ALLOWING THE PROGRAMMING SYSTEM TO SUCCESSFULLY PERFORM INTERROGATIONS. THE SERIAL CABLE APPEARED OLD AND DAMAGED DUE TO AGING. THE FRAYED SERIAL CABLE HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600085 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073771

    Patients

    Seq Age Sex Outcome Treatment
    1