BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INSPIRE MODEL 3028 IPG

    MDR report key: 11987364 · Received June 11, 2021

    Report

    Report Number
    3007666314-2021-00074
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    January 28, 2022
    Report Date
    November 28, 2022
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005656
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO THE PHYSICIAN WITH AN OPEN AND RED IPG INCISION WITH DISCHARGE. PHYSICIAN PRESCRIBED ANTIBIOTICS. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CONTINUED SWELLING AND WEEPING AT THE CHEST INCISION. PHYSICIAN PRESCRIBED IV ANTIBIOTICS FOR 6 WEEKS. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH POTENTIAL INFECTION AT THE CHEST POCKET. PHYSICIAN REMOVED THE IPG AND SENSE LEAD AND FLUSHED THE CHEST POCKET WITH VANCOMYCIN AND NORMAL SALINE.

    Description of Event or Problem · 0

    POST COMPLETION OF INSPIRE REMOVAL PROCEDURE FOR INFECTION THE PATIENT WAS PLACED ON A PICC LINE. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO PHYSICIAN (B)(6) 2021 WITH SIGNS OF INFECTION IN THE IPG POCKET. PHYSICIAN PRESCRIBED ANTIBIOTICS (300 MG CLINDAMYCIN, 3 TIMES DAILY) TO ADDRESS THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879726 INSPIRE MODEL 3028 IPG INSPIRE MODEL 3028 IPG MNQ INSPIRE MEDICAL SYSTEMS 3028 10855728005656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O