BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVUITY, INC.

    MDR report key: 7170453 · Received January 5, 2018

    Report

    Report Number
    3011394215-2017-00011
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 12, 2017
    Report Date
    December 13, 2017
    Manufacturer
    INVUITY, INC
    Product Code
    GEI
    UDI-DI
    00816728020158
    PMA / PMN Number
    K162053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP CONVERSATION WAS CONDUCTED IN PERSON WITH THE ATTENDING SURGEON AND ADDITIONAL INFORMATION WAS ACQUIRED. DURING THE ICD BATTERY CHANGE OUT, THE PHYSICIAN WAS DISSECTING NEAR THE LEAD (ST. JUDE COPOLYMER) AT 40 WATTS COAG. THE PHYSICIAN ACKNOWLEDGED THAT THE SETTING MIGHT HAVE BEEN TOO HIGH AND CAUSED THE DAMAGE TO THE INSULATION. THE PHYSICIAN STATED FUTURE DISSECTIONS AROUND LEADS WILL BE PERFORMED AT LOWER POWER SETTINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AN INVUITY REPRESENTATIVE ON (B)(4) 2017, THAT THE INSULATION OF A LEAD WAS ACCIDENTALLY DAMAGED DURING A BATTERY REPLACEMENT OF AN ICD. A SUTURE SLEEVE WAS APPLIED OVER THE DAMAGED AREA OF THE INSULATION. THE CASE WAS COMPLETED WITH NO FURTHER INCIDENT AND NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13874 INVUITY, INC. PHOTONBLADE GEI INVUITY, INC PB1 17100511 00816728020158

    Patients

    Seq Age Sex Outcome Treatment
    1