BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1870534 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16931
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERICARDIAL EFFUSION WAS SUCCESSFULLY DRAINED AND THE PATIENT MOVED TO ICU FOR MONITORING. NO ALLEGATIONS AGAINST BSC PRODUCTS AS A CAUSE OR CONTRIBUTOR TO THE OBSERVED CLINICAL OBSERVATION. THE LEAD REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AT THE CONCLUSION OF SYSTEM IMPLANT, THE PATIENT EXHIBITED SUSTAINED HYPOTENSION REQUIRING INOTROPIC SUPPORT. A TRANSTHORACIC ECHOCARDIOGRAPHY WAS PERFORMED, NOTING EVIDENCE OF A PERICARDIAL EFFUSION; NO HEMODYNAMIC COLLAPSE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention