BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 24993530 · Received April 26, 2026

    Report

    Report Number
    3012563838-2026-00018
    Event Type
    Injury
    Date Received
    April 26, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 26, 2026
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00081000338005
    PMA / PMN Number
    P180036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED ON (B)(6) 2026 THAT AFTER LOSING A LOT OF WEIGHT (REPORTEDLY 60KG) THAT THEIR OPTIMIZER SMART IPG WAS "UNSTABLE" IN POCKET, THE POCKET AREA WAS PAINFUL, AND CHARGING THE IPG IS "DIFFICULT." THE PATIENT WAS SEEN BY THE PHYSICIAN AND IMPULSE DYNAMICS FIELD REPRESENTATIVE AT THE HOSPITAL ON (B)(6) 2026, AND INTERROGATION OF THE IPG SHOWED VERY LOW SENSING OF THE RV LEAD. AN X-RAY SHOWED A LOWER IPG POSITION WITHIN THE POCKET, WHICH WAS CAUSING STRAIN ON BOTH LEADS. THE SMART IPG AND ATTACHED LEADS WERE EXPLANTED ON (B)(6) 2026 AND WERE REPLACED WITH A NEW OPTIMIZER SMART MINI IPG AND LEADS. THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST THE OPTIMIZER SMART IPG MALFUNCTIONED IN ANY WAY. THE EXPLANTED IPG IS CURRENTLY BEING SOUGHT FOR EVALUATION FROM THE HOSPITAL, BUT IT IS UNCLEAR AT THIS TIME WHETHER THE DEVICE IS CAPABLE OF BEING RETURNED TO IMPULSE DYNAMICS OR IF IT HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127831 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X10 H4562 00081000338005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other