BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD

    MDR report key: 11801633 · Received May 10, 2021

    Report

    Report Number
    3007666314-2021-00055
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 10, 2021
    Manufacturer
    INSPIRE MEDICAL SYSTEMS
    Product Code
    MNQ
    UDI-DI
    10855728005632
    PMA / PMN Number
    P130008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AND SWELLING AT THE INTERCOSTAL INCISION SITE. THE PHYSICIAN PERFORMED A REVISION SURGERY TO ADDRESS THE PATIENT¿S ISSUE, REMOVING THE SENSE LEAD AND REPLACING IT WITH A NEW SENSE LEAD LOCATED IN THE IPG POCKET (2 INCISION METHOD). THIS INTERVENTION RESOLVED THE PATIENT¿S ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695502 INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD INSPIRE MODEL 4340 RESPIRATORY SENSING LEAD MNQ INSPIRE MEDICAL SYSTEMS 4340 10855728005632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R