BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INSPIRE MODEL 3028 IPG

    MDR report key: 11646022 · Received April 9, 2021

    Report

    Report Number
    3007666314-2021-00038
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    April 23, 2021
    Report Date
    October 14, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005656
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CELLULITIS AT THE IPG INCISION AREA ON (B)(6) 2021 FOLLOWING SURGICAL REMOVAL OF THE INSPIRE SYSTEM ON (B)(6) 2021. TESTING SHOWED STAPH INFECTION. PHYSICIAN ADMITTED THE PATIENT TO THE HOSPITAL TO TREAT THE INFECTION AND PERFORMED SURGERY TO REMOVE DAMAGED TISSUE TO ADDRESS THE ACTIVE INFECTION. INFECTION IS ON-GOING.

    Description of Event or Problem · 0

    PHYSICIAN REPORTS THAT THE INFECTION HAS RESOLVED.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE PHYSICIAN WITH AN INJURY UNRELATED TO INSPIRE AT THE IPG SITE. THE SITE BECAME INFECTED, LEADING TO AN INTERNAL INFECTION. PHYSICIAN SURGICALLY REMOVED INSPIRE SYSTEM TO TREAT INFECTION, RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542327 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R