BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE MODEL 3028 IPG

    MDR report key: 8271401 · Received January 23, 2019

    Report

    Report Number
    3007666314-2019-00007
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 27, 2019
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005465
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HEADACHES, SWOLLEN FACE, AND A RASH ON THE TORSO AND THE RIGHT SIDE OF THE FACE. ALLERGIC REACTION HAS RESOLVED WITHOUT ANY ADDITIONAL INTERVENTION. THE PATIENT FOLLOW-UP INDICATED THE ISSUES ALL WENT AWAY THROUGH THE HEALING PROCESS.

    Description of Event or Problem · 1

    PATIENT SAW IMPLANTING PHYSICIAN ON (B)(6) AND WAS PRESCRIBED 800 MG OF IBUPROFEN AND PREDNISONE DUE TO FACIAL SWELLING. PATIENT LATER EXPERIENCED SIGNIFICANT RASH ON TORSO AND THE RIGHT SIDE OF FACE. PATIENT SAW PHYSICIAN AGAIN ON (B)(6) 2019. PHYSICIAN PRESCRIBED BENADRYL, AMOXICILLIN-CLAV 875-125 MG TAB TWICE A DAY AND METHYLPREDNISOLONE 4 MG DOSE PACK (21). THERAPY ACTIVATION DELAYED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62932 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005465

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R