BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 25125031 · Received May 8, 2026

    Report

    Report Number
    3012563838-2026-00025
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 8, 2026
    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

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY IMPULSE DYNAMICS FIELD REPRESENTATIVES ON (B)(6) 2026 THAT A PATIENT IMPLANTED WITH AN OSM IPG HAD THEIR DEVICE EXPLANTED AND REPLACED. TWO MONTHS PRIOR, THE PATIENT HAD CALLED THE IMPULSE DYNAMICS SUPPORT HOTLINE TO REPORT PALPABLE, VISIBLE POCKET STIMULATION. WHEN THE PATIENT WAS SEEN IN-PERSON, THEY REPORTED SENSATIONS FELT ON BOTH LEADS, AND THE POCKET STIMULATION WAS VISIBLE ON THEIR CHEST. THE ID REP DEACTIVATED THE V1 LEAD AND REDUCED THE VOLTAGE ACROSS THE V2 LEAD, WHICH RESULTED IN PATIENT SYMPTOMS IMPROVING. THE PATIENT AND PHYSICIAN OPTED TO LEAVE THE DEVICE ON AT THE REDUCED VOLTAGE UNTIL THE LEAD REVISION PROCEDURE, WHICH OCCURRED ON (B)(6) 2026. DURING THE REVISION PROCEDURE, THE PHYSICIAN WAS ABLE TO REPLICATE AND CONFIRM THE POCKET STIMULATION, WHICH DISSIPATED UPON IMPLANTATION OF THE REPLACEMENT IPG AND LEADS. THE EXPLANTED IPG IS CURRENTLY BEING DECONTAMINATED AT AN APPROVED DECONTAMINATION FACILITY. IT WILL THEN BE RETURNED TO ID USA IN (B)(6) FOR A FULL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424638 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5349 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other