BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMIZER SMART MINI

    MDR report key: 19497548 · Received June 10, 2024

    Report

    Report Number
    3012563838-2024-00022
    Event Type
    Death
    Date Received
    June 10, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 30, 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

    IMPULSE DYNAMICS WAS RECENTLY MADE AWARE OF A DEVICE EXPLANTATION AND DEATH OF A PATIENT WHO WAS PREVIOUSLY IMPLANTED WITH AN OPTIMIZER SMART MINI (OSM) IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT'S OSM IPG HAD BEEN EXPLANTED ON (B)(6) 2024 DUE TO A BACTERIAL INFECTION THE PATIENT APPEARED TO HAVE DEVELOPED IN THE IPG POCKET AND BLOOD STREAM. THE DEVICE REMAINED IN HOSPITAL QUARANTINE, DURING WHICH CULTURES WERE TAKEN AND TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS. AROUND THE TIME THE DEVICE WAS SENT TO IMPULSE DYNAMICS USA IN MARLTON, NEW JERSEY FOR FURTHER EVALUATION, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. THE DATE OF DEATH WAS NOTED AS (B)(6) 2024, AND THE CAUSE OF DEATH WAS LISTED AS A GI BLEED. ONCE RECEIVED AT ID USA MARLTON, THE DEVICE WAS IMMEDIATELY SHIPPED TO AN APPROVED DECONTAMINATION FACILITY TO BE DECONTAMINATED. THE DECONTAMINATED DEVICE WAS RECEIVED BY ID USA ON JUNE 5, 2024 FOR A COMPLETE EVALUATION. THE DEVICE PASSED ALL FINAL ELECTRONIC CONTROLS TESTING AND NO MALFUNCTIONS OCCURRED. A REVIEW OF DEVICE STERILIZATION RECORDS WAS CONDUCTED AND NO ANOMALIES WERE FOUND. THERE IS NO EVIDENCE TO INDICATE THE IPG WAS NOT FULLY FUNCTIONAL AT THE TIME OF EXPLANT.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. THE DEVICE COMPLETED DECONTAMINATION AND WAS RECEIVED BY IMPULSE DYNAMICS USA ON (B)(6) 2024. THE PRODUCT EVALUATION WAS COMPLETED ON (B)(6) 2024. THE DEVICE WAS INTERROGATED WITHOUT ISSUE AND THE DEVICE LOGS INDICATED NO RECENT FAILURE(S) HAD OCCURRED. THE DEVICE PASSED ALL FINAL ELECTRONIC CONTROLS TESTING WITHOUT ANY FAILURES OR ERRORS. THE REMOVAL OF THE DEVICE IS ATTRIBUTABLE TO THE PATIENT'S CONDITION AT THE TIME OF THE EVENT. THIS DEVICE WILL BE SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173194 OPTIMIZER SMART MINI IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X11 H5106 00810003380098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| D