BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE

    MDR report key: 7936254 · Received October 4, 2018

    Report

    Report Number
    3007666314-2018-00041
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 4, 2018
    Manufacturer
    INSPIRE MEDICAL SYSTEMS INC
    Product Code
    MNQ
    UDI-DI
    10855728005496
    PMA / PMN Number
    P130008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS OF THE SENSING LEAD REVEALED THAT THE DIP CPAT INSULATION ON THE SENSE LEAD HAD BEEN CUT, POSSIBLY DURING IMPLANT PROCEDURE. THIS DAMAGE WOULD BE CONSISTENT WITH THE DEVICE ISSUES REPORTED.

    Description of Event or Problem · 1

    INITIAL REPORT WAS THAT PATIENT REQUIRED DEVICE SETTING ADJSUTMENTS BUT SUBSEQUENTLY IT WAS MADE KNOWN TO INSPIRE THAT ISSUES WITH SENSING AND WAVEFORMS LED TO TWO REVISION SURGERIERS, ONE TO REPLACE THE SENSING LEAD (B)(6) 2018), AND THEN LATER (B)(6) 2018) THE IPG WAS REPLACED. THIS RESOLVED THE ISSUES AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774117 INSPIRE SENSING LEAD MNQ INSPIRE MEDICAL SYSTEMS INC 4323 10855728005496

    Patients

    Seq Age Sex Outcome Treatment
    1 Other