BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK SQ

    MDR report key: 3041093 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02651
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P910077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. SUBSEQUENTLY INFORMATION WAS RECEIVED THAT THIS DEVICE WAS USED EXTERNALLY AS A TEMPORARY PACER UNTIL THE NEW NON BOSTON SCIENTIFIC SYSTEM WAS IMPLANTED. THIS PRODUCT WAS THEN REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143205 ENDOTAK SQ IMPLANTABLE LEAD DTB CPI - DEL CARIBE 0085

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R 6947| 1852| T180| 4137| T135| 0085