BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2151732 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07307
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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

    THIS LEAD WAS REMOVED FROM SERVICE AS A RESULT. NO FURTHER INFORMATION IS EXPECTED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID APPEAR TO BE FRACTURED, ALTHOUGH FRACTURE WAS NOT VISIBLE UNDER FLOUROSCOPY. INCREASING PACE IMPEDANCE AND THRESHOLDS WERE THE OBSERVED ISSUES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4136| 1290| S603| 4470| 4469