BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVUITY, INC.

    MDR report key: 7170446 · Received January 5, 2018

    Report

    Report Number
    3011394215-2017-00010
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Report Date
    December 7, 2017
    Manufacturer
    INVUITY, INC
    Product Code
    GEI
    UDI-DI
    00816728020158
    PMA / PMN Number
    K162053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION WAS REQUESTED, BUT NO NEW DETAILS HAVE BEEN PROVIDED AS OF 01/05/2018.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AN INVUITY REPRESENTATIVE ON (B)(6) 2017 THAT DURING A BATTERY REPLACEMENT OF AN ICD THE INSULATION OF A LEAD WAS ACCIDENTALLY MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13865 INVUITY, INC. PHOTONBLADE GEI INVUITY, INC PB1 UNKNOWN 00816728020158

    Patients

    Seq Age Sex Outcome Treatment
    1