BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD

    MDR report key: 8725470 · Received June 22, 2019

    Report

    Report Number
    2124215-2019-12109
    Event Type
    Injury
    Date Received
    June 22, 2019
    Date of Event
    June 12, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526599200
    PMA / PMN Number
    P110042/S077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE ADDITIONAL INFORMATION FROM THE FIELD INDICATING THAT THE PATIENT ALSO HAD EROSION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PRODUCT WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518947 EMBLEM S-ICD IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 3501 153944 00802526599200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R