BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3053286 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04754
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 26, 2013
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT THIS LEAD WAS REPOSITIONED SUCCESSFULLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP HIGH THRESHOLDS RESULTING IN LOSS OF CAPTURE WAS NOTED. A REPOSITIONING PROCEDURE HAS BEEN SCHEDULED FOR THIS DISLODGED RIGHT ATRIAL LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155538 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R