BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCOR

    MDR report key: 2172894 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-11660
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    October 17, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO LOW IMPEDANCE AND HIGH THRESHOLD MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCOR IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 404-04

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention (B)(4)| S606| 4470| (B)(4)| 1176| 4457| (B)(4)| 1294| MISMATCH