BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 11369799 · Received February 23, 2021

    Report

    Report Number
    2124215-2021-02984
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 19, 2021
    Report Date
    July 16, 2021
    Manufacturer
    OSCOR
    Product Code
    LWS
    UDI-DI
    00802526585968
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED ELECTRODE WAS THOROUGHLY INSPECTED AND ANALYZED. RESISTANCE TESTS WERE COMPLETED TO ASSESS ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE BODY FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY ELECTRODE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANT OF A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DEFIBRILLATION THRESHOLD (DFT) TESTING WAS UNSUCCESSFUL AT CONVERTING THE PATIENT WITH 80 JOULE SHOCKS. THE S-ICD AND THIS CHRONIC ELECTRODE ALSO EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF 142, 144 AND 150 OHMS FOLLOWING SHOCK DELIVERY. IT WAS NOTED THAT THE PATIENT HAD A LARGER CHEST SIZE. THE S-ICD WAS ATTEMPTED, BUT NOT IMPLANTED AND THIS CHRONIC ELECTRODE WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DEFIBRILLATION THRESHOLD (DFT) TESTING WAS UNSUCCESSFUL AT CONVERTING THE PATIENT WITH 80 JOULE SHOCKS. THE S-ICD AND THIS CHRONIC ELECTRODE ALSO EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF 142, 144 AND 150 OHMS FOLLOWING SHOCK DELIVERY. IT WAS NOTED THAT THE PATIENT HAD A LARGER CHEST SIZE. THE S-ICD WAS ATTEMPTED, BUT NOT IMPLANTED AND THIS CHRONIC ELECTRODE WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266332 EMBLEM S-ICD IMPLANTABLE LEAD LWS OSCOR 3401 A132313 00802526585968

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R