BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3243008 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02223
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 REPORTED THAT THE PATIENT¿S PAST MEDICAL HISTORY INCLUDES SLEEP APNEA. THERE IS NO MENTION OF INTERVENTIONS TAKEN FOR SLEEP APNEA. THE PATIENT IS NOTED TO BE MORBIDLY OBESE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344258 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2497

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other