BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 17012218 · Received May 26, 2023

    Report

    Report Number
    2124215-2023-26718
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    June 1, 2015
    Report Date
    May 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED AT THAT TIME.

    Description of Event or Problem · 0

    THIENEL, MANUELA, ET AL. (2022). "IMPAIRMENT OF QUALITY OF LIFE IN PATIENTS WITH IMPLANTED SUBCUTANEOUS CARDIOVERTER DEFIBRILLATOR (S-ICD) COMPARED TO IMPLANTED TRANSVENOUS CARDIOVERTER DEFIBRILLATOR THERAPY". PATIENT PREFERENCE AND ADHERENCE 2022:16 3027-3033. HTTPS://DOI.ORG/10.2147/PPA.S378741. IT WAS REPORTED IN A JOURNAL ARTICLE REVIEW OF 52 PATIENTS IMPLANTED WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND 52 PATIENTS IMPLANTED WITH A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (TV-ICD), 27.7% OF S-ICD PATIENTS EXPECTED THEIR QUALITY OF LIFE TO IMPROVE BY EITHER DEACTIVATION OR EXPLANTATION OF THEIR DEVICE. BOTH S-ICD AND TV-ICD GROUPS REPORTED INAPPROPRIATE SHOCK (IAS) THERAPY, WITH A RATE OF 4.8 IAS PER PATIENT YEAR FOR THE S-ICD GROUP. PATIENTS REPORTED PAIN, MENTAL STRESS, AND FEAR AS A RESULT OF THEIR SHOCKS. PATIENT ALSO REPORTED DISCOMFORT AND PAIN FROM THE S-ICD POCKET ITSELF. OF NOTE, THE STUDY LOOKED AT PATIENT IMPLANTED WITH 2ND- OR 3RD-GENERATION S-ICD (BOSTON SCIENTIFIC SERIAL NUMBERS A209 AND A219). NO ADDITIONAL INFORMATION BESIDES THE JOURNAL ARTICLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575965 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other