BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK PLUS

    MDR report key: 2151461 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06169
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVY
    PMA / PMN Number
    P910077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    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 CAPPED AND SURGICALLY ABANDONED DUE TO A SUSPECTED 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 PLUS IMPLANTABLE LEAD NVY HISTORICAL PUERTO RICO 0075

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R (B)(4)| (B)(4)| (B)(4)