BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 10642070 · Received October 7, 2020

    Report

    Report Number
    2124215-2020-19659
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 24, 2020
    Report Date
    February 24, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526544101
    PMA / PMN Number
    P110042/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO CORRECT THE EXPLANT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO INAPPROPRIATE SHOCKS WERE REPORTED INVOLVING THIS DEVICE. A REQUEST FOR REVIEW OF THE EPISODES WAS SENT TO TECHNICAL SERVICES (TS). A REVIEW OF THE DATA BY TS NOTED THAT THE LAST TREATED AND UNTREATED EPISODES SHOW THE LOSS OF SIGNAL AND NON PHYSIOLOGIC ARTIFACTS. TS NOTED THAT THIS ISSUE COULD BE RELATED TO AN ELECTRODE INTEGRITY ISSUE OR A SENSE B NODE ISSUE; IMPAIRMENT OF THE CONTACT IN THE DEVICE HEADER TO THE CONTACT OF THE SENSING NODE B. AN X-RAY WOULD BE NEEDED FOR FURTHER INVESTIGATION. TS FURTHER DISCUSSED THAT THE SECONDARY VECTOR APPEARED TO BE A VIABLE VECTOR AND IN CASE NO NOISE IS POSSIBLE TO RECREATE. ADDITIONAL INFORMATION NOTED THAT THE SYSTEM WAS EXPLANTED PER THE PATIENT REQUEST. TO DATE THE SYSTEM HAS NOT BEEN RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO INAPPROPRIATE SHOCKS WERE REPORTED INVOLVING THIS DEVICE. A REQUEST FOR REVIEW OF THE EPISODES WAS SENT TO TECHNICAL SERVICES (TS). A REVIEW OF THE DATA BY TS NOTED THAT THE LAST TREATED AND UNTREATED EPISODES SHOW THE LOSS OF SIGNAL AND NON PHYSIOLOGIC ARTIFACTS. TS NOTED THAT THIS ISSUE COULD BE RELATED TO AN ELECTRODE INTEGRITY ISSUE OR A SENSE B NODE ISSUE; IMPAIRMENT OF THE CONTACT IN THE DEVICE HEADER TO THE CONTACT OF THE SENSING NODE B. AN X-RAY WOULD BE NEEDED FOR FURTHER INVESTIGATION. TS FURTHER DISCUSSED THAT THE SECONDARY VECTOR APPEARED TO BE A VIABLE VECTOR AND IN CASE NO NOISE IS POSSIBLE TO RECREATE. ADDITIONAL INFORMATION NOTED THAT THE SYSTEM WAS EXPLANTED PER THE PATIENT REQUEST AND WILL NOT BE RETURNED AS A BOSTON SCIENTIFIC REPRESENTATIVE WAS NOT PRESENT AT THE EXPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO INAPPROPRIATE SHOCKS WERE REPORTED INVOLVING THIS DEVICE. A REQUEST FOR REVIEW OF THE EPISODES WAS SENT TO TECHNICAL SERVICES (TS). A REVIEW OF THE DATA BY TS NOTED THAT THE LAST TREATED AND UNTREATED EPISODES SHOW THE LOSS OF SIGNAL AND NON PHYSIOLOGIC ARTIFACTS. TS NOTED THAT THIS ISSUE COULD BE RELATED TO AN ELECTRODE INTEGRITY ISSUE OR A SENSE B NODE ISSUE; IMPAIRMENT OF THE CONTACT IN THE DEVICE HEADER TO THE CONTACT OF THE SENSING NODE B. AN X-RAY WOULD BE NEEDED FOR FURTHER INVESTIGATION. TS FURTHER DISCUSSED THAT THE SECONDARY VECTOR APPEARED TO BE A VIABLE VECTOR AND IN CASE NO NOISE IS POSSIBLE TO RECREATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110937 EMBLEM S-ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION A209 225489 00802526544101

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R