BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBLEM MRI S-ICD

    MDR report key: 12459844 · Received September 13, 2021

    Report

    Report Number
    2124215-2021-27592
    Event Type
    Death
    Date Received
    September 13, 2021
    Date of Event
    July 12, 2021
    Report Date
    September 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526584404
    PMA / PMN Number
    P110042/S058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF THIS INVESTIGATION, ANOTHER REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH THIS EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) RECEIVED TWO INAPPROPRIATE SHOCKS (IAS) DUE TO T-WAVE OVERSENSING. DURING A POST-SHOCK FOLLOW-UP, THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION AND TREATMENT DUE TO SEVERE HYPERKALEMIA. IT WAS DETERMINED THAT THE HYPERKALEMIA CAUSED LARGER THAN EXPECTED T-WAVES, WHICH SUBSEQUENTLY CONTRIBUTED TO SYSTEM OVERSENSING AND ASSOCIATED IAS. THE PROGRAMMED DEVICE SETTINGS AT THE TIME OF THE INAPPROPRIATE THERAPY INCLUDED THE FOLLOWING: CONDITIONAL SHOCK ZONE 220 BPM, THERAPY SHOCK ZONE 250 BPM, ALTERNATE VECTOR (GAIN 1X), AND THE SMART PASS FILTER WAS ON. NO CHANGES WERE REPORTED FOR THE DEVICE SETTINGS; HOWEVER, THE PATIENTS HYPERKALEMIA WAS CORRECTED/RESOLVED (NO POST-CORRECTION VALUES WERE PROVIDED). IT WAS CONFIRMED THAT THE OBSERVED SYSTEM OVERSENSING WAS RESOLVED FOLLOWING CORRECTION OF THE PATIENTS HYPERKALEMIA. THE PATIENT WAS 35 WEEKS PREGNANT AT THE TIME OF THE IAS. UPON ARRIVAL AT THE HOSPITAL, THE PHYSICIAN CONFIRMED AN INTRAUTERINE FETAL DEATH (IUFD) HAD OCCURRED. THE STILLBORN FETUS WAS DELIVERED FOUR DAYS LATER. IT WAS ALSO REPORTED THAT, 12 DAYS PRIOR TO THE IAS AND HOSPITAL ADMISSION, INTRAUTERINE GROWTH RETARDATION (DUE TO PLACENTAL INSUFFICIENCY) WAS IDENTIFIED. AN INQUIRY HAS BEEN MADE AS TO WHETHER THERE CAN BE ANY CONNECTION BETWEEN THE IAS AND IUFD; HOWEVER, BOSTON SCIENTIFIC HAS NO EVIDENCE TO SUPPORT A CONNECTION. FURTHER INVESTIGATION IS BEING CONDUCTED TO OBTAIN ALL AVAILABLE RELEVANT MEDICAL INFORMATION. THE ROOT CAUSE OF THE HYPERKALEMIA IS ALSO UNDER FURTHER INVESTIGATION BY THE PATIENTS INTERNIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355937 EMBLEM MRI S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A219 245825 00802526584404

    Patients

    Seq Age Sex Outcome Treatment
    1 Death