BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 6516708 · Received April 24, 2017

    Report

    Report Number
    2124215-2017-07097
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    April 7, 2017
    Report Date
    April 7, 2017
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. REFERENCE: BROUWER, T. F., D. YILMAZ, ET AL. (2016). "LONG-TERM CLINICAL OUTCOMES OF SUBCUTANEOUS VERSUS TRANSVENOUS IMPLANTABLE DEFIBRILLATOR THERAPY." J AM COLL CARDIOL 68(19): 2047-2055.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A JOURNAL ARTICLE OF A STUDY COMPARING THE LONG-TERM CLINICAL OUTCOMES OF SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THERAPY. DURING THE COURSE OF THE STUDY, SEVERAL DIFFERENT COMPLICATIONS WERE REPORTED THAT OCCURRED WITH THE PATIENTS IMPLANTED WITH S-ICD SYSTEMS: 1 ELECTRODE DISLODGEMENT, 8 INFECTIONS/EROSIONS, 1 DEFIBRILLATION THRESHOLD (DFT) TEST FAILURE, 2 INAPPROPRIATE SENSING, 20 THAT EXPERIENCED INAPPROPRIATE SHOCKS, 1 DEVICE FAILURE, 1 TWIDDLER'S SYNDROME, AND 2 DEATHS. ONE DEATH WAS LISTED AS NON-CARDIAC; THE OTHER DEATH WAS LISTED AS CARDIAC RELATED. THE SPECIFIC SERIAL NUMBER INFORMATION FOR THE S-ICD DEVICES OR ELECTRODES WAS NOT PROVIDED IN THE ARTICLE AND WAS UNABLE TO BE OBTAINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298204 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 3010