BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19962895 · Received August 12, 2024

    Report

    Report Number
    3012563838-2024-00027
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    February 20, 2025
    Report Date
    March 11, 2025
    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

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. THE FULL PRODUCT EVALUATION OF THE EXPLANTED IPG BY THE IMPULSE DYNAMICS PRODUCT DEVELOPMENT TEAM WAS COMPLETED ON (B)(6) 2025. THE DEVICE WAS UNABLE TO COMMUNICATE WITH ANY EXTERNAL CHARGER OR PROGRAMMER, WHICH WAS CONSISTENT WITH THE INITIAL COMPLAINT. THE DEVICE WAS OPENED AND IT WAS DISCOVERED THAT A FUSE HAD BLOWN. ALL OF THE IPG'S PRIOR REPORTED PROBLEMS ARE CONSISTENT WITH A BLOWN FUSE, BUT IT REMAINS UNKNOWN HOW THE FUSE WAS BLOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A PATIENT WHO WAS IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG) THREE DAYS PRIOR REPORTED AN A9 ERROR CODE DISPLAYING ON THEIR CHARGER WHEN THEY ATTEMPTED TO CHARGE THEIR IPG. THE PATIENT WAS SEEN IN-OFFICE 9 DAYS LATER ON (B)(6) 2024. DURING THE APPOINTMENT, AN IMPULSE DYNAMICS FIELD REPRESENTATIVE ATTEMPTED TO INTERROGATE THE PATIENT'S IPG TO DETERMINE THE TYPE OF A9 ERROR THAT THE DEVICE PREVIOUSLY EXHIBITED. THE IPG WAS UNABLE TO BE INTERROGATED AND THE TYPE AND CAUSE OF THE A9 ERROR COULD NOT BE DETERMINED. THE PATIENT STATED THEY WOULD PREFER THEIR PRIMARY ELECTROPHYSIOLOGIST TO BE PRESENT TO HELP DETERMINE NEXT STEPS. THE PATIENT'S EP IS CURRENTLY OUT OF TOWN, SO THE PATIENT WILL WAIT TO BE SEEN UNTIL THEIR EP RETURNS AND A FOLLOW-UP APPOINTMENT CAN BE SCHEDULED. UNTIL THEN, THE ROOT CAUSE OF THE IPG ERROR AND THE DISPOSITION OF THE DEVICE IS PENDING FURTHER EVALUATION.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. IT WAS REPORTED ON (B)(6) 2024 LHAT THIS IPG HAD BEEN EXPLANTED AND REPLACED WITH A NEW IPG. THE NEW IPG WAS IMPLANTED WITHOUT INCIDENT AND CCM THERAPY IS BEING SUCCESSFULLY DELIVERED BY THE NEW DEVICE. THE EXPLANTED IPG REMAINED IN THE PATHOLOGY DEPARTMENT OF THE HOSPITAL PER THEIR PROCEDURE UNTIL (B)(6) 2024 WHEN IT WAS SHIPPED TO IMPULSE DYNAMICS USA IN (B)(4). THE EXPLANTED IPG WAS RECEIVED BY ID USA ON (B)(6) 2024. THE IPG WAS X-RAYED WITHIN ITS SEALED BIOHAZARD BAG AND NO ANOMALIES WERE FOUND. THE DEVICE WAS THEN SENT OUT FOR DECONTAMINATION AT AN APPROVED DECONTAMINATION FACILITY. THE DECONTAMINATED DEVICE WAS RETURNED TO ID USA ON OCTOBER 3, 2024. AN INITIAL PRODUCT EVALUATION CONFIRMED THE DEVICE COULD NOT BE INTERROGATED DUE TO AN INABILITY OF THE PROGRAMMER TO ESTABLISH A LINK WITH THE DEVICE. REPEATED ATTEMPTS AT INTERROGATION USING THE PROGRAMMER WERE UNSUCCESSFUL. THE DEVICE CURRENTLY REMAINS UNDER EVALUATION DURING WHICH A ROOT CAUSE OF THE INTERROGATION ISSUES WILL BE SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301656 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5108 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other