BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6284151 · Received January 27, 2017

    Report

    Report Number
    1644487-2017-03093
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    June 1, 2016
    Report Date
    January 27, 2017
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN'S OFFICE THAT THE VNS WAS HELPING THE PATIENT WITH HER SEIZURES, BUT NOW SHE HAS HAD AN INCREASE. SYSTEM DIAGNOSTICS WERE RUN AND LOOKED OK, WHICH CONFIRMED THE VNS WAS WORKING AS INTENDED AND THE DEVICE WAS NOT AT END OF SERVICE. IT WAS NOT REPORTED IF THE INCREASE IN SEIZURES WAS ABOVE OR BELOW PRE-VNS BASELINE LEVELS. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66655 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS - HOUSTON 102 202689

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR