BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1851837 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14267
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE CLINICAL OBSERVATIONS, ANALYSIS WOULD NOT BE REQUIRED SHOULD THE PRODUCTS GET RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED A (B)(6) INFECTION AT THE DEVICE POCKET SITE. AS A RESULT, THE PACING SYSTEM WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED DURING THE EXPLANT PROCEDURE.

    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 89 YR Required Intervention S603| 4088| 4087