BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1871651 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18364
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE PATIENT WITH THIS RIGHT ATRIAL (RA) LEAD THAT THE DEVICE WAS EXPLANTED DURING A REVISION PROCEDURE DUE TO THEIR LEADS PROTRUDING OUT OF THEIR SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 0186| T180| N119| 4592| 4087