BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 18797486 · Received February 28, 2024

    Report

    Report Number
    3012563838-2024-00010
    Event Type
    Death
    Date Received
    February 28, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 7, 2024
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. ON (B)(6) 2024, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE WAS INFORMED BY A REPRESENTATIVE FROM THE HOSPITAL THAT THIS PATIENT HAD EXPIRED. DUE TO THIS, THE HOSPITAL IS NOT WILLING TO RELEASE THE EXPLANTED OSM IPG BACK TO IMPULSE DYNAMICS USA FOR FURTHER EVALUATION. THERE IS NO EVIDENCE TO INDICATE THE DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, AN IMPULSE DYNAMICS REPRESENTATIVE WAS INFORMED OF THE EXPLANT OF AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) THAT HAD TAKEN PLACE THE DAY PRIOR, FEBRUARY 5. SINCE THE INITIAL IMPLANTATION THAT OCCURRED ON (B)(6) 2024, THE PATIENT HAD DEVELOPED A FUNGAL INFECTION, WHICH PROMPTED THE DECISION MADE BY THE CARDIOTHORACIC SURGEON TO EXPLANT THE PATIENT'S IPG. THE EXPLANT WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATIONS, AND THE PATIENT WAS TRANSFERRED POST-OP TO THE ICU TO RECOVER FROM THE SURGERY AS WELL AS STAVE OFF THE INFECTION WITH IV ANTIBIOTICS. A REVIEW OF THE DEVICE'S STERILITY RECORDS REVEALED NO ABNORMALITIES, AND THERE IS NO INDICATION THAT THE IPG ITSELF CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION IN ANY WAY. NOTE THAT THE INITIAL OSM IPG IMPLANTATION PROCEDURE FOR THIS PATIENT HAD TO BE RESCHEDULED TWICE DUE TO INFUSION PORT ACCESS ISSUES AND INFECTION. THE DEVICE IS CURRENTLY UNDER QUARANTINE AT THE HOSPITAL AWAITING ADDITIONAL TESTING FOR INFECTION TYPE. DEPENDING ON THE TYPE AND SEVERITY OF THE INFECTION, THE DEVICE WILL EITHER BE DISCARDED (EX. IF MRSA DETECTED) OR WILL BE SENT TO THE IMPULSE DYNAMICS SITE IN MARLTON, NEW JERSEY FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896325 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5070 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| D| O