BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913112 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16920
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PHYSICIAN

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED PACING IMPEDANCE AND PACING THRESHOLDS. THE PHYSICIAN ELECTED TO REVISE THE LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE AND DURING EXTRACTION THE INNER LUMEN SEPARATED FROM THE OUTER INSULATION. THE LEAD TIP WAS STILL INTACT IN THE PATIENT'S ANATOMY. THE REMAINING PORTION OF THE LEAD WAS LEFT IN THE PATIENT AND THE LEAD BODY WAS CAPPED. THERE WILL BE NO RETURN OF PRODUCT NOTHING REMAINED OF THE EXTRACTED CONDUCTORS EXPECT PIECES OF UNRAVELED COILS AND WAS DISCARDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20439 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4480| 4457| 1291