BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4152511 · Received August 11, 2014

    Report

    Report Number
    3009448963-2014-00177
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 30, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) EXPERIENCED SYNCOPE AND RECEIVED SEVERAL SHOCKS FOR A VENTRICULAR FIBRILLATION (VF). A REVIEW OF THE EPISODES REVEALED THAT ALTHOUGH THE VF WAS DETECTED, THE TIME TO THERAPY DELIVERY WAS MUCH LONGER THAN EXPECTED AND RESULTED IN UP TO FOUR SHOCKS TO CONVERT THE ARRHYTHMIA. IN ADDITION, THE SHOCK IMPEDANCE VALUES WERE ALSO HIGHER THAN EXPECTED, HOWEVER, THEY WERE STILL IN NORMAL RANGE. BOSTON SCIENTIFIC TECHNICAL SVS (TS) WAS CONTACTED AND AN ENGINEER DISCUSSED THAT THIS COULD BE RELATED TO A PLACEMENT ISSUE WITH THE SYSTEM. AN X-RAY WAS PERFORMED AND REVEALED THAT THE DEVICE WAS NOT IMPLANTED IN AN OPTIMAL POSITION. THE POSITION OF THE ELECTRODE WAS UNABLE TO BE DETERMINED. THE PHYSICIAN DECIDED TO EXPLANT THE S-ICD SYSTEM AND REPLACE IT WITH A TRANSVENOUS SYSTEM DUE TO THE PT'S HISTORY. NO ADD'L ADVERSE PT EFFECTS WERE REPORTED. THE DEVICE AND ELECTRODE WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476048 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

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