BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A NEITHER LEADS IMPLANTED NOR DEVICE NOT IMPLANTED ARE SUSPECT AT THIS TIME

    MDR report key: 14167930 · Received April 21, 2022

    Report

    Report Number
    3012563-2022-00001
    Event Type
    Death
    Date Received
    April 21, 2022
    Date of Event
    April 18, 2022
    Report Date
    April 19, 2022
    Manufacturer
    IMPULSE DYNAMICS (USA), INC.
    Product Code
    NVN
    PMA / PMN Number
    P180036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STATEMENT RECEIVED FROM ATTENDING PHYSICIAN DOES NOT IMPLICATE EITHER THE LEADS WHICH WERE IMPLANTED OR THE IPG WHICH WAS NOT IMPLANTED AS A POTENTIAL CAUSE OF THE PATIENT'S DEMISE. ACCORDING TO PHYSICIAN PATIENT WAS VERY ILL PRIOR TO PROCEDURE. IT HAS NOT YET BEEN DETERNINED WHETHER OR NOT AUTOPSY WILL BE PERFORMED. THIS APPEARS TO BE AN UNFORTUNATE DEATH OF PATIENT DURING PROCEDURE INTENDED TO IMPLANT OPTIMIZER SMART IPG HOWEVER PATIENT DIED PRIOR TO IPG PLACEMENT AND THERE IS NO APPARENT RELATIONSHIP BETWEEN EITHER LEADS EMPLOYED OR IPG AND PATIENT'S DEATH. IN FACT CODE WAS ONLY CALLED AT REQUEST OF FAMILY.

    Description of Event or Problem · 0

    DURING THE IMPLANT PROCEDURE OF AN OPTIMIZER SMART IMPLANTABLE PULSE GENERATOR, TWO BOSTON SCIENTIFIC INGEVITY+ LEADS WERE INTRODUCED INTO THE PATIENT'S BODY FOR LEAD PLACEMENT. THE OPTIMIZER SMART WAS NOT REMOVED FROM THE STERILE PACKAGING NOR WAS DEVICE IMPLANT EVEN ATTEMPTED. WHILE PLACING THE SECOND LEAD, THE FIRST LEAD DISLODGED. THE ANESTHESIOLOGIST NOTED THAT THE PATIENT'S OXYGEN SATURATIONS WERE DROPPING, AND THE PATIENT'S EKG RHYTHM CHANGED. THE SURGEON INFORMED THE STAFF TO START CHEST COMPRESSIONS AS THE PATIENT WAS NOT PERFUSING. RESUCITATION EFFORTS WERE CONTINUED FOR A LENGTHY TIME ALL THE WHILE WITH THE PHYSICIAN DISCUSSING THE PATIENT'S CONDITION WITH THE FAMILY. THE FAMILY MADE THE DECISION TO STOP CPR EFFORTS TO AVOID PATIENT BEING PERMANENTLY INCAPACITATED AND TOLD THE PHYSICIAN TO CEASE ALL LIFE SAVING EFFORTS UPON WHICH THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004398 N/A NEITHER LEADS IMPLANTED NOR DEVICE NOT IMPLANTED ARE SUSPECT AT THIS TIME N/A NEITHER LEADS IMPLANTED NOR DEVICE NOT IMPLANTED ARE SUSPECT AT THIS TIME NVN IMPULSE DYNAMICS (USA), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death