BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMIZER SMART

    MDR report key: 18450007 · Received January 5, 2024

    Report

    Report Number
    3012563838-2024-00001
    Event Type
    Death
    Date Received
    January 5, 2024
    Date of Event
    December 5, 2023
    Report Date
    January 4, 2024
    Manufacturer
    IMPULSE DYNAMICS USA, INC.
    Product Code
    QFV
    PMA / PMN Number
    P180036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST THE PATIENT'S SMART IPG CAUSED OR CONTRIBUTED TO THE HEART FAILURE LEADING TO DEATH. HOWEVER, THE ALERT CODE PRESENT DURING IPG CHARGING LEADING UP TO THE PATIENT'S DEATH REMAINS A REPORTABLE EVENT BASED ON THE CRITERIA OUTLINED IN THE FDA "GUIDANCE FOR INDUSTRY AND STAFF: MEDICAL DEVICE REPORTING FOR MANUFACTURERS" ISSUED ON NOVEMBER 8, 2016.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT IMPLANTED WITH AN OPTIMIZER SMART IPG DEVICE CONTACTED IMPULSE DYNAMICS CUSTOMER SERVICE TO REPORT THEY RECEIVED AN ERROR CODE 1 (DETECTED CHANGE IN ELECTRICAL IMPEDANCE OF THE LEADS) WHILE ATTEMPTING TO CHARGE THE DEVICE. THE PATIENT INFORMED CS THAT THEY WERE IN THE HOSPITAL AND HAD BEEN CARDIOVERTED THE DAY BEFORE (NOVEMBER 30) DUE TO ATRIAL FIBRILLATION. IMPULSE DYNAMICS FIELD STAFF CONTACTED THE PATIENT AND ASKED THEM TO WAIT 24 HOURS BEFORE ATTEMPTING TO CHARGE AGAIN, AND TO REACH OUT IF THE ERROR CODE PERSISTED. FOLLOW-UP COMMUNICATION ATTEMPTS WITH THE PATIENT BY ID FIELD STAFF ON DECEMBER 3 AND 4 WENT UNANSWERED, BUT ON (B)(6), THE IMPLANTING PHYSICIAN INFORMED ID FIELD STAFF THAT THE PATIENT HAD BEEN IN THE ICU AFTER BEING IMPLANTED WITH AN LMPELLA LEFT VENTRICULAR ASSIST DEVICE. WHEN ID FIELD STAFF ARRIVED AT THE ICU LATER THAT DAY TO INTERROGATE THE SMART IPG, THEY WERE INFORMED THAT THE HOSPITAL STAFF HAD TO CARDIOVERT THE PATIENT TWICE, BUT THE PATIENT SUBSEQUENTLY CODED AND HAD TO BE RESUSCITATED. UPON INTERROGATION OF THE SMART IPG, THE DEVICE WAS FOUND TO BE IN MAGNET MODE, ATTRIBUTABLE FROM A MAGNET HAVING BEEN PLACED OVER THE DEVICE DURING ONE OF THE CARDIOVERSIONS. IN ADDITION, THE IPG WAS NOT ABLE TO DELIVER THERAPY DUE TO THE LS SIGNAL HAVING SHIFTED, AGAIN ATTRIBUTABLE TO CARDIOVERSION AND RESUSCITATION ATTEMPTS. THE PHYSICIAN INFORMED ID FIELD STAFF THAT THE PROGNOSIS FOR THE PATIENT WAS "NOT GOOD" AND NOT TO WORRY ABOUT CCM THERAPY AT THAT POINT. THE IPG WAS LEFT ON BUT WITH THE THERAPY DELIVERY FUNCTION DISABLED. ON (B)(6), THE PHYSICIAN NOTIFIED ID FIELD STAFF THAT THE PATIENT HAD EXPIRED AFTER FAMILY MEMBERS CHOSE TO INITIATE THE DNR PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435613 OPTIMIZER SMART IMPLANTABLE PULSE GENERATOR QFV IMPULSE DYNAMICS USA, INC. CCM X10 H4796

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death BIOTRONIK DR DEFIBRILLATOR.| IMPELLA LEFT VENTRICULAR ASSIST DEVICE.