BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 8184890 · Received December 20, 2018

    Report

    Report Number
    3007666314-2018-00053
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    December 13, 2018
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    10855728005397
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOW UP REPORT TO 3007666314-2018-00053: PATIENT REPORTED THE STIMULATION LEAD TRACTION AND PAIN. THE ISSUE WAS RESOLVED BY RE-TUNNELING THE STIMULATION LEAD AND REPOSITIONING THE IPG. BASED ON THE ABOVE INFORMATION, THE ROOT CAUSE WAS CONCLUDED AS SUB-OPTIMAL IMPLANT LOCATION/DEPTH/SIZE.

    Description of Event or Problem · 1

    PATIENT IS EXPERIENCING TRACTION ON THE STIMULATION LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023207 INSPIRE NEUROSTIMULATION LEAD MNQ INSPIRE MEDICAL SYSTEMS INC 4063 10855728005397

    Patients

    Seq Age Sex Outcome Treatment
    1 Other