BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2162544 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08246
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 POST OPERATIVE CHECK REVEALED THAT THIS RIGHT VENTRICULAR LEAD HAD DISLODGED. THIS LEAD WAS REPOSITIONED SUCCESSFULLY AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE REPOSITIONING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4087| S606| 4480| 4088