BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 20152193 · Received September 5, 2024

    Report

    Report Number
    3012563838-2024-00031
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    October 2, 2024
    Report Date
    October 30, 2024
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING AN OPTIMIZER SMART MINI (OSM) IMPLANT PROCEDURE ON (B)(6) 2024, AN IMPLANTABLE PULSE GENERATOR (IPG) THAT PASSED ALL PRIOR TESTING COULD NOT BE CONNECTED TO BOTH LEADS AFTER BEING SET IN THE POCKET. THE DEVICE CONNECTED TO THE FIRST V1 LEAD WITHOUT ISSUE, BUT UPON ATTEMPTING TO CONNECT THE SECOND V2 LEAD, THE TORQUE WRENCH WOULD NOT ENGAGE WITH EITHER THE PROXIMAL OR DISTAL SET SCREW. BOTH SCREWS WERE DISCOVERED AT THIS TIME TO BE OUT OF ALIGNMENT FROM THEIR RESPECTIVE HOUSINGS, AT WHICH POINT THE DECISION WAS MADE BY THE PHYSICIAN TO SWAP OUT THE IPG. A NEW IPG WAS PREPARED, OPENED, CONNECTED TO BOTH LEADS WITHOUT ISSUE, AND SET IN THE POCKET. THE EXPLANTED IPG WAS SENT BACK TO IMPULSE DYNAMICS USA, INC. UPON RECEIPT, THE DEVICE WAS IMMEDIATELY SENT OUT FOR DECONTAMINATION AT AN APPROVED DECONTAMINATION FACILITY. THE DECONTAMINATED DEVICE WAS RECEIVED BY ID USA ON AUGUST 21, 2024. A PRELIMINARY X-RAY INITIAL EVALUATION OF THE DEVICE CONFIRMED ITS V2 SET SCREWS WERE MISALIGNED. AND THE CAUSE OF THE SCREWS' MISALIGNMENT APPEARS TO BE EXCESSIVE TORQUING AND UNSCREWING ATTEMPTS WITH THE WRENCH. WHILE SUCH ACTIONS ARE CONSIDERED MISUSE ATTRIBUTABLE TO IMPROPER SURGICAL TECHNIQUE, A FULL EVALUATION OF THE DEVICE IS PENDING AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MOR. THE FULL PRODUCT EVALUATION OF THE DECONTAMINATED DEVICE WAS COMPLETED ON OCTOBER 2, 2024. THE V2 SET SCREWS COULD NOT BE RETURNED TO THEIR PROPER POSITIONS IN THEIR CAVITIES, AFTER ATTEMPTING TO ENGAGE THEM WITH A HEX WRENCH, DUE TO THEIR SEVERE MISALIGNMENT. THE OTHER SET SCREWS WERE RUN TO FULL DEPTH AND BACKED OUT WITHOUT ISSUE. THE ROOT CAUSE OF THE SET SCREW MISALIGNMENT WAS DETERMINED TO BE IMPROPER USE DURING THE IMPLANT PROCEDURE; THE SET SCREWS WERE MOST LIKELY EXCESSIVELY UNSCREWED, CAUSING THEM TO FULLY BACK OUT AND BECOME MISALIGNED. THIS MISALIGNMENT PREVENTED THEM FROM BEING RETURNED TO THEIR PROPER POSITIONS IN THEIR CAVITIES. THIS IPG WILL BE SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073852 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5044 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other