BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2910049 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15286
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOSS OF CAPTURE WAS NOTED ON THIS RIGHT VENTRICULAR LEAD. A FLUOROSCOPY REVEALED THAT THIS LEAD HAD DISLODGED. A REPOSITIONING PROCEDURE TOOK PLACE, AND THIS RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16979 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4097| S606| 4096