BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3904261 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09282
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING AN UNEVENTFUL SYSTEM IMPLANT, POST POCKET CLOSURE, THIS RIGHT ATRIAL (RA) LEAD DISLODGED. THE PHYSICIAN IMMEDIATELY REOPENED THE POCKET AND SUCCESSFULLY REPOSITIONED THE RA LEAD. TWO DAYS LATER, THE PATIENT EXHIBITED A PERICARDIAL EFFUSION. TACHY THERAPY WAS DEACTIVATED AND THE EFFUSION TREATED. FOLLOWING COMPLETION OF EFFUSION RESOLUTION, TACHY THERAPY WAS PROGRAMMED BACK ON, WITH NORMAL SYSTEM MEASUREMENTS OBSERVED. THE SOURCE OF THE PERICARDIAL EFFUSION WAS LATER CONFIRMED TO HAVE BEEN THE RESULT OF A PERFORATION. SYSTEM MEASUREMENTS AND THE PATIENT'S STATUS REMAIN STABLE. THE PATIENT HAS BEEN TRANSFERRED FOR NORMAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384951 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4677| G179| 4096| 0695