BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 2911820 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16280
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16354 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R 4285| K173| 1298| 1232| 4137| 4271