BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6027133 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-13618
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 15, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    UDI-DI
    00802526531279
    PMA / PMN Number
    P910073/S077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679528 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296 00802526531279

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 0296| 4471| E162