BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3243174 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02226
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 REPORTED THAT THE PATIENT HAS A MEDICAL HISTORY OF OBSTRUCTIVE SLEEP APNEA AND CONTINUES TO USE A CPAP MACHINE WITHOUT DIFFICULTY. THE RELATIONSHIP OF THE SLEEP APNEA TO VNS IS UNCLEAR FROM THE NOTES, AND ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. IT IS UNCLEAR IF THE SLEEP APNEA IS A PRE-EXISTING MEDICATION CONDITION. THE VNS WAS INTERROGATED AT THIS VISIT AND THE PATIENT WAS NOTED TO BE DOING WELL. ADDITIONALLY, THE NOTES INDICATE THE PATIENT APPEARED FOR A CLINIC VISIT WITH RECENT REPROGRAMMING OF THE VNS DUE TO INCREASED FREQUENCY OF SEIZURES. HOWEVER IN PREVIOUS NOTES, THERE IS NO MENTION OF INCREASED SEIZURES AND THE PATIENT'S SEIZURE FREQUENCY IMPROVED WITH HIGHER CURRENT SETTINGS ON (B)(6) 2013 WHERE THE CURRENTS WERE INCREASED BY 0.25MA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342314 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 016318

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention