BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2072392 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00761
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    January 1, 2005
    Report Date
    October 5, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN'S OFFICE THAT THE PATIENT'S VNS HAD BEEN OFF FOR SEVERAL YEARS. IT WAS UNCLEAR IF THE VNS WAS PROGRAMMED OFF OR IF THE BATTERY HAD BECOME FULLY DEPLETED AS THE NEAR END OF SERVICE, OR NEOS, INDICATOR WAS OBSERVED A YEAR PRIOR TO THE DATE PROVIDED BY THE PHYSICIAN'S OFFICE. THE PATIENT REPORTED VIA FACEBOOK COMMENT THAT SHE LET THE BATTERY RUN DEAD AND DID NOT HAVE IT REPLACED. NO REPLACEMENT SURGERY IS KNOWN TO HAVE OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DOES NOT THINK HER VNS IS HELPING HER ANYMORE. SHE STATED THAT THE FIRST 2 YEARS SHE HAD THE VNS IT WORKED WELL, HOWEVER THE LAST 8 OR 9 YEARS SHE HAS HAD SPORADIC SEIZURES AND THE VNS DOES NOT SEEM TO BE CONTROLLING THEM LIKE IT DID. SHE IS GOING TO DISCUSS FURTHER WITH HER NEUROLOGIST TO DECIDE IF SHE SHOULD GO AHEAD WITH GENERATOR REPLACEMENT OR NOT AS THE DEVICE IS CURRENTLY SHOWING ERI = YES. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 014818

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other