BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2173099 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10403
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED, OR UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP SHORTLY AFTER IMPLANT, ABNORMAL IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE WERE NOTED ON THIS RIGHT VENTRICULAR LEAD DUE TO DISLODGEMENT. A REVISION PROCEDURE WAS DONE AND THIS LEAD WAS REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention