BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 1952011 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23143
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    Z-1144-09 TO Z-1145-09
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 1230| (B)(4)| N118| 0125| H175| H135| 6987| 4471| 1861| 1810| (B)(4)| 4513