BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1874988 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18282
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED SECONDARY DUE TO PATIENT INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED SECONDARY DUE TO POCKET INFECTION. A NEW BOSTON SCIENTIFIC CRM DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN.

    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 55 YR Required Intervention 0157| 4087| 1861