BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2153549 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06178
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER AN IMPLANT PROCEDURE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE PATIENT DEVELOPED A POCKET INFECTION AND THEN BECAME HOSPITALIZED. ANTISEPTIC DRESSINGS WERE PLACED ON THE POCKET INFECTION. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention