BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2211868 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01828
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER (MO/DAY/YR), CORRECTED DATA: FOLLOW-UP REPORT #1 INADVERTENTLY HAD THE INITIAL REPORT DATE AND NOT THE SUPPLEMENTAL REPORT DATE. THE DATE SHOULD HAVE BEEN (B)(6) 2012.

    Description of Event or Problem · 1

    ADDITIONAL ATTEMPTS WERE MADE WITH THE SITE AND THEY REPORTED THAT ALL THEIR SERIAL CORDS WERE WORKING AND IT IS UNKNOWN WHICH WAS THE ORIGINAL THAT WAS WITH THE PROBLEM PROGRAMMING SYSTEM.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN WAS UNABLE TO COMMUNICATE WITH PT'S GENERATOR AT INITIAL IMPLANT. ANOTHER PROGRAMMING SYSTEM IS USED TO COMPLETE THE SURGERY AND THE SITE DID NOT TROUBLESHOOT AT THAT TIME. THE COMPANY REPRESENTATIVE WENT TO THE SITE TO TROUBLESHOOT THE ISSUE. WHEN THE WAND WAS EXCHANGED WITH THE SITE'S WAND USING THE SITES HANDHELD AND SERIAL CABLE INTERROGATION WAS SUCCESSFUL. WHEN THE SITE WAND WAS USED WITH THE COMPANY REPRESENTATIVE'S HANDHELD AND SERIAL CABLE INTERROGATION WAS UNSUCCESSFUL. THE ISSUE WAS BELIEVED TO BE ISOLATED TO THE WAND. THE WAND WAS RETURNED TO THE MFR FOR EVALUATION. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED. THE PHYSICIAN HAS NOT HAD ANY FURTHER ISSUES WITH THEIR PROGRAMMING SYSTEM. THE SITE HAD THEIR SERIAL CABLE REPLACED IN ADDITION TO THE WAND SINCE IT WAS NOT TESTED INDEPENDENTLY. THE SERIAL CABLE FUNCTIONED CORRECTLY DURING TROUBLESHOOTING, HOWEVER, SINCE IT HAS NOT BEEN RETURNED FOR PRODUCT ANALYSIS AND THAT IT HAS BEEN USED SINCE THE REPORTED EVENT IT CANNOT BE CONFIRMED THAT IT WAS NOT THE CAUSE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 874809

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR