BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 1950636 · Received January 6, 2011

    Report

    Report Number
    2124215-2011-00260
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0062

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R 1510| 1600| 6931| (B)(4)| E102| 0063| 6836| 1857| 1746| 1550| 0062| 0041| 0040| 0030