BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCOR PY

    MDR report key: 1952270 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23740
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K913158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 REMOVED FROM SERVICE DUE TO A PATIENT INFECTION. DURING THE EXPLANT THE LEADS WERE BROKEN AND SUBSEQUENTLY CAPPED AND ABANDONED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCOR PY IMPLANTABLE LEAD NVN CPI PLANT - ST. PAUL 4440

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R 4440| 1821| 0125| E110| A155