BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3081188 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01174
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED ON (B)(6) 2013 WHICH INDICATED THAT THE VNS PATIENT HAS A PAST MEDICAL HISTORY OF OBSTRUCTIVE SLEEP APNEA AND EXPERIENCES A SHORTNESS OF BREATH WHEN THE VNS GOES OFF. THE PHYSICIAN LATER REPORTED THAT THE PATIENT HAD A HISTORY OF MILD SLEEP APNEA AND THE PATIENT HAS ONLY BEEN SEEN ONCE, ON (B)(6) 2013. THE PATIENT'S MOST RECENT SETTINGS WERE NOTED TO BE OUTPUT - 1.75 MA, FREQUENCY - 20 HZ, PULSE WIDTH - 500 MICROSECONDS ( DECREASED TO 250 MICROSECONDS), ON-TIME - 30 SECONDS, OFF-TIME - 1.1 MINUTE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183143 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other