BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2990134 · Received March 5, 2013

    Report

    Report Number
    1644487-2013-00593
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR REVIEW. IT WAS NOTED ON THIS PATIENT'S HISTORY THAT THEY HAVE OBSTRUCTIVE SLEEP APNEA. NO OTHER INFORMATION WAS NOTED IN REGARDS TO THIS EVENT. IT IS UNKNOWN WHEN IT WAS FIRST DIAGNOSED. GOOD FAITH ATTEMPTS MADE THUS FAR AND NO FURTHER INFORMATION HAS BEEN ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93498 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 2530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other