BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2912140 · Received January 11, 2013

    Report

    Report Number
    1644487-2013-00138
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS BEING HOSPITALIZED FOR APNEA EPISODES. IT WAS UNKNOWN WHEN THE APNEA BEGAN OR IF IT WAS OCCURRING WITH STIMULATION. THE PHYSICIAN WAS CURIOUS THE PERCENTAGE OF PATIENT WITH VNS THAT HAD APNEA BUT THERE WAS NO INFORMATION AS TO IF THE PHYSICIAN BELIEVED THAT THE APNEA WAS CAUSED OR MADE WORSE BY VNS. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN'S OFFICE UNWILLING AND UNABLE TO GIVE INFO ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18935 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202126

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| O