BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART IPG

    MDR report key: 24993563 · Received April 26, 2026

    Report

    Report Number
    3012563838-2026-00019
    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

    PHYSICIANS DECIDED MONTHS AGO THAT THIS PATIENT NEEDED AN LS LEAD SWAP TO FIX ITS UNDERSENSING. THIS PROCEDURE WAS POSTPONED MULTIPLE TIMES UNTIL IT WAS SCHEDULED FOR AND OCCURRED ON (B)(6) 2026. DURING EXTRACTION, THE RV LEAD WAS DAMAGED, SO THE SURGEON HAD TO EXTRACT BOTH THE LS AND RV LEADS. AS TWO NEW LEADS WERE ATTEMPTED TO BE PLACED, THE TORTUOSITY OF VEINS IN THE LEFT SIDE TOGETHER WITH THE LOW SENSING OF THE MOST APICAL ELECTRODE MADE LEAD REPLACEMENT IMPOSSIBLE. THE FINAL DECISION OF THE PHYSICIANS WAS TO EXTRACT THE ENTIRE OPTIMIZER SMART IPG AND ATTACHED LEADS. THE PHYSICIAN WANTS TO IMPLANT A NEW OPTIMIZER SMART MINI IPG AS THE PATIENT IS A GOOD RESPONDER TO CCM THERAPY, BUT THIS HAS NOT YET OCCURRED. THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST THE OPTIMIZER SMART IPG MALFUNCTIONED IN ANY WAY; THE PROBLEM WAS TRACED TO THE LS LEAD. 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
    474748 OPTIMIZER SMART IPG IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X10 H4584 00081000338005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other