BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM S-ICD

    MDR report key: 16182961 · Received January 17, 2023

    Report

    Report Number
    2124215-2023-01594
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 10, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526599200
    PMA / PMN Number
    P110042/S077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION H6 FIELD, CODE A072202 ADDED.

    Additional Manufacturer Narrative · 0

    CORRECTION H6 FIELD, CODE A072202 ADDED. THE RETURNED ELECTRODE WAS THOROUGHLY INSPECTED AND ANALYZED. THE ELECTRODE WAS RETURNED SEVERED APPROXIMATELY 22 CM FROM THE TERMINAL END. ONLY THE PROXIMAL SEGMENT WAS RETURNED. 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, ONLY THE TYPICAL SURGERY RELATED DAMAGE WAS NOTED, BUT IS NOT CONSIDERED ABNORMAL. 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 THIS ELECTRODE EXHIBITED LOW SHOCK IMPEDANCES OUT OF RANGE DURING THE MANUAL MEASUREMENT IN THE IMPLANT PROCEDURE. ONCE THE PHYSICIAN CLOSED BOTH INCISIONS COMPLETELY, THE SHOCK IMPEDANCE VALUE WAS IN RANGE. THE PHYSICIAN DID NOT WANT TO SHOCK THIS PATIENT DUE TO A VERY LOW EJECTION FRACTION. THIS ELECTRODE WAS EXPLANTED DUE TO THE PATIENT DID NOT WANT THE SYSTEM IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED LOW SHOCK IMPEDANCES OUT OF RANGE DURING THE MANUAL MEASUREMENT IN THE IMPLANT PROCEDURE. ONCE THE PHYSICIAN CLOSED BOTH INCISIONS COMPLETELY, THE SHOCK IMPEDANCE VALUE WAS IN RANGE. THE PHYSICIAN DID NOT WANT TO SHOCK THIS PATIENT DUE TO A VERY LOW EJECTION FRACTION. THIS ELECTRODE WAS EXPLANTED DUE TO THE PATIENT DID NOT WANT THE SYSTEM IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS ELECTRODE EXHIBITED LOW IMPEDANCES DURING THE MANUAL MEASUREMENT IN THE IMPLANT PROCEDURE. ONCE THE PHYSICIAN CLOSED BOTH INCISIONS COMPLETELY, THE SHOCK IMPEDANCE VALUE WAS IN RANGE. THE PHYSICIAN DID NOT WANT TO SHOCK THIS PATIENT DUE TO A VERY LOW EJECTION FRACTION. THIS ELECTRODE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425337 EMBLEM S-ICD ELECTRODE LWS BOSTON SCIENTIFIC CORPORATION 3501 224517 00802526599200

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female