BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2911246 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15870
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 23, 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 THIS RIGHT ATRIAL LEAD DISPLAYED LOSS OF CAPTURE. A RIGHT ATRIAL LEAD DISLODGMENT WAS CONFIRMED, AND A REPOSITIONING PROCEDURE TOOK PLACE. THIS LEAD WAS NOT SUCCESSFULLY REPOSITIONED AND THUS WAS EXPLANTED. THIS RIGHT ATRIAL LEAD WILL NOT BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17820 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4543| N119| 0185| 4096