BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2050272 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03083
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS EVENT WILL BE UPATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) HAD DISLODGED. DURING A REPOSITIONING PROCEDURE THE HELIX OF THIS LEAD WOULD NOT EXTEND AND RETRACT. THIS LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITOR LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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