BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 3912190 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12641
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    K893957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 EFFECTS REPORTED. THE PRODUCT WAS PARTIALLY REMOVED BUT STILL IN THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390870 TRANSVENOUS IMPLANTABLE LEAD LWS CPI - DEL CARIBE 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 1184| 1130| 4047| 4261| 1190