BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19258896 · Received May 7, 2024

    Report

    Report Number
    3012563838-2024-00019
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 20, 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

    ON APRIL 8, 2024, IMPULSE DYNAMICS REPRESENTATIVES WERE NOTIFIED OF AN IMPENDING DEVICE EXPLANT PROCEDURE FOR AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) DEVICE. THE DEVICE HAD PREVIOUSLY DISPLAYED A9 ERROR MESSAGES WHEN CHARGING HAD BEEN ATTEMPTED BY THE PATIENT. SPECIFICALLY, ON (B)(6) 2023, THE PATIENT REPORTED TO AN IMPULSE DYNAMICS REPRESENTATIVE THAT THEIR CHARGER SHOWED A THERMOMETER ICON FOLLOWED BY AN "A9" CODE. THE PATIENT'S IPG WAS INTERROGATED BY AN IMPULSE DYNAMICS FIELD REPRESENTATIVE LATER THAT DAY, WHICH YIELDED A "TELEMET ERROR: DOWN_TEMPERATURE_INTEGRITY _2" ERROR. EVEN AFTER THE DEVICE WAS SUCCESSFULLY RESET, ATTEMPTS BY THE IMPULSE DYNAMICS FIELD REP TO CHARGE THE DEVICE, INCLUDING THE USE OF ANOTHER CHARGER AND A SPECIAL CHARGE MODE FOR THE IPG, WERE UNSUCCESSFUL. THE IPG WAS THEN REPROGRAMMED TO DELIVER THERAPY FOR 5 HOURS PER DAY INSTEAD OF THE PREVIOUSLY CONFIGURED 7, IN AN ATTEMPT TO SAVE BATTERY UNTIL THE DEVICE ENTERED DOWN MODE AGAIN. ANALYSIS OF THE DEVICE LOGS INDICATED THE SOURCE OF THESE CHARGING PROBLEMS COULD BE RELATED TO A HARDWARE ISSUE WITH THE DEVICE RATHER THAN A FIRMWARE ISSUE. AFTER MULTIPLE CONVERSATIONS BETWEEN THE IMPULSE DYNAMICS REP, PATIENT, AND IMPLANTING PHYSICIAN, THE DECISION WAS MADE ON (B)(6) 2024 TO REPLACE THE DEVICE. THE REVISION PROCEDURE OCCURRED ON (B)(6) 2024, AND THE EXPLANTED DEVICE WAS RECEIVED BY IMPULSE DYNAMICS USA IN MARLTON, NEW JERSEY ON APRIL 22, 2024. INITIAL X-RAYS OF THE DEVICE WITHIN THE PROTECTIVE, SEALED BAG REVEALED ONE OF THE SETSCREWS OF THE DEVICE WAS POSSIBLY CROSS-THREADED OR DISLODGED, BUT THIS IS UNLIKELY RELATED TO THE OBSERVED BEHAVIOR. NO OTHER SIGNS OF DAMAGE WERE OBSERVED. THE DEVICE WAS THEN SENT OUT TO BE DECONTAMINATED AT AN APPROVED AND VALIDATED DECONTAMINATION FACILITY. ONCE THE DEVICE RETURNS FROM DECONTAMINATION, A MORE DETAILED EVALUATION OF THE DEVICE WILL TAKE PLACE.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. AFTER THE DEVICE RETURNED FROM DECONTAMINATION, A FULL PRODUCT EVALUATION WAS PERFORMED. DURING THE EVALUATION, THE DEVICE EXHIBITED THE SAME, PREVIOUSLY REPORTED ISSUE OF NOT BEING ABLE TO BE CHARGED FOR SUSTAINED PERIODS OF TIME WITHOUT PROVIDING AN ERROR OR DROPPING ITS WIRELESS CONNECTION TO A CHARGER. FURTHER ANALYSIS CONFIRMED THIS IPG HAS THE SAME, KNOWN INTERNAL HARDWARE ISSUE PREVIOUSLY DOCUMENTED IN 3 OTHER DEVICES. THE ROOT CAUSE OF THE ISSUE WAS TRACED TO A PART OF THE MANUFACTURING AND SHIPPING PROCESS. THIS WAS RECTIFIED AS PART OF THE CHANGES APPROVED BY FDA FOR THE OSM SYSTEM UNDER (B)(4). THIS DEVICE WILL BE SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668667 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H4839 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other