BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 2173294 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10297
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS DEVICE AND RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS PRESENTED WITH A POST SURGICAL INFECTION. THE DEVICE POCKET WAS SWOLLEN AND ANTIBIOTICS WERE ADMINISTERED. THE PATIENT IS SCHEDULED FOR A FOLLOW UP. NO ADVERSE PATIENT EFFECTS WERE ASSOCIATED WITH THE ANTIBIOTICS GIVEN.

    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 F110| 0185| 0181