BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 20169900 · Received September 9, 2024

    Report

    Report Number
    3012563838-2024-00032
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    October 16, 2024
    Report Date
    November 12, 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 (B)(6) 2024, A PATIENT IN EUROPE CALLED THE IMPULSE DYNAMICS (ID) SUPPORT HOTLINE CLAIMING AN A9 ERROR CODE APPEARED ON THEIR CHARGER WHILE ATTEMPTING TO CHARGE THEIR OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT WAS SEEN TWO DAYS LATER AT THE HOSPITAL, AT WHICH POINT NO CONNECTION COULD BE ESTABLISHED BETWEEN THE IPG AND ANY CHARGER OR PROGRAMMER. ALL ATTEMPTS TO CHARGE THE DEVICE WERE UNSUCCESSFUL: CHARGING WAS POSSIBLE FOR APPROXIMATELY 1 O SECONDS AFTER WHICH THE CONNECTION BETWEEN THE CHARGER AND IPG WOULD BE DROPPED. MULTIPLE ALTERNATIVE METHODS RECOMMENDED BY THE ID PRODUCT DEVELOPMENT TEAM TO ESTABLISH A CONNECTION WITH THE DEVICE PROVED EQUALLY UNSUCCESSFUL. AS THE REASON FOR THE IPG BEING UNABLE TO SUSTAIN CONNECTIONS WITH PROGRAMMERS AND CHARGERS COULD NOT BE ESTABLISHED, THE DECISION WAS MADE BY THE IMPLANTING PHYSICIAN TO REPLACE THE DEVICE. THE REPLACEMENT PROCEDURE OCCURRED ON (B)(6) 2024 AND THE EXPLANTED DEVICE IS CURRENTLY EN ROUTE TO ID USA. ONCE RECEIVED, THE DEVICE WILL UNDERGO A FULL EVALUATION AND THE INVESTIGATION WILL CONTINUE.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. THE DECONTAMINATED DEVICE WAS RECEIVED BY IMPULSE DYNAMICS USA FOR EVALUATION ON OCTOBER 16, 2024. A FULL PRODUCT EVALUATION WAS PERFORMED ON THE DEVICE AND WAS COMPLETED ON OCTOBER 22, 2024. DURING THE EVALUATION, THE ISSUE IN WHICH THE IPG COULD NOT ESTABLISH A CONNECTION BETWEEN A PROGRAMMER OR CHARGER WAS OBSERVED, AS PREVIOUSLY REPORTED IN THE INITIAL COMPLAINT. THE SOURCE OF THE IPG PROBLEMS WAS TRACED TO A BLOWN FUSE. HOWEVER, THE MANNER IN WHICH THE FUSE WAS BLOWN REMAINS UNCLEAR; THE CHARACTERISTICS OF THE FUSE FAILURE ARE NOT EXACTLY THE SAME AS PREVIOUSLY OBSERVED BLOWN FUSES. THE DEVICE HAS BEEN SHIPPED TO OUR CONTRACT MANUFACTURER, WHERE EFFORTS REMAIN ONGOING WITH BOTH PRODUCT DEVELOPMENT TEAMS TO DETERMINE THE ROOT CAUSE OF THE FUSE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1601293 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5137 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other