BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4101858 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02395
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 20, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING AN INCREASE IN SEIZURES FOLLOWING A SERIES OF X-RAYS. THE PHYSICIAN INDICATED THAT THE CHANGE IN SEIZURES CANNOT BE PINPOINTED TO VNS, BUT THAT DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PHYSICIAN PLANS TO INVESTIGATE THE PATIENT'S EPILEPSY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582576 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 NI

    Patients

    Seq Age Sex Outcome Treatment
    1