BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2191915 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01637
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT HE HAD AN ISSUE WITH HIS PROGRAMMING SYSTEM. THE PHYSICIAN STATED THAT BECAUSE THE FLASHCARD WAS LOOSE HE WAS NOT ABLE TO USE THE PROGRAMMING SYSTEM TO INTERROGATE A PT. A COMPANY REP WAS UNABLE TO OBTAIN ANY MORE INFO FROM THE SITE CONCERNING THE ISSUES, BUT THE EQUIPMENT WAS CHECKED. THE REP FOUND THAT THE FLASHCARD WAS INSERTED AS REQUIRED FOR OPERATION, AND THERE WAS NO ISSUE FOUND WITH THE SYSTEM THAT COULD BE FOUND. IT IS NOT KNOWN IF THERE WAS AN ISSUE WITH THE PROGRAMMING SYSTEM OR THE PT'S DEVICE THAT PREVENTED THE INTERROGATION. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE REPORTER'S VNS PROGRAMMING WAND, HANDHELD COMPUTER, AND FLASHCARD WERE RETURNED FOR ANALYSIS. NO ANOMALIES WERE IDENTIFIED WITH ANY OF THE COMPONENTS, AND ALL DEVICES PERFORMED PER SPECIFICATION.

    Description of Event or Problem · 1

    REPORTER INDICATED THERE HAVE BEEN "ABSOLUTELY NO ISSUES INTERROGATING ANY VNS PATIENTS" SINCE THE NEW VNS PROGRAMMING SYSTEM WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1