BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 25104486 · Received May 6, 2026

    Report

    Report Number
    3012563838-2026-00021
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 6, 2026
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    UDI-DI
    00810003380098
    PMA / PMN Number
    P180036/S007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A PATIENT IMPLANTED WITH AN OSM IPG WAS INITIALLY SEEN ONE WEEK POST-IMPLANT "DUE TO [AN] INTERMITTENT SHOCKING FEELING" THAT WAS FURTHER IDENTIFIED AS FEELING STIMULATION FROM BOTH LEADS. UPON INTERROGATION, THE IPG WAS FUNCTIONING NORMALLY, BUT THE ATTACHED LS LEAD WAS FOUND TO BE UNDERSENSING. THE PATIENT WAS GOING TO BE SEEN AGAIN DURING THE ONE-MONTH POST-IMPLANT FOLLOW-UP, AFTER THE ACUTE PERIOD WAS OVER, BUT FIVE DAYS LATER, THE PATIENT PRESENTED TO THE ER WITH INTENSE CHEST PAIN. IT WAS DISCOVERED THAT THE CHEST PAIN WAS THE RESULT OF A RIGHT VENTRICULAR PERFORATION BY THE V1 LEAD AND SUBSEQUENT PERICARDIAL EFFUSION. THE SURGICAL TEAM PERFORMED OPEN HEART SURGERY ON THE PATIENT ON (B)(6) 2026 TO REPAIR THE RIGHT VENTRICLE. DURING THE SURGERY, THE TEAM REMOVED THE IPG AND BOTH LEADS. HOSPITAL POLICY IS THAT ALL REMOVED DEVICES MUST BE RETAINED; THEREFORE, THE IPG WILL NOT BE AVAILABLE FOR EVALUATION BY IMPULSE DYNAMICS USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80238 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5442 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other