BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2050322 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03554
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT RETURND FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD HAD SUSTAINED A FRACTURE. IT WAS REPORTED THAT NEARLY 40% OF THE LEAD BODY WAS COILED BEHIND THE PACEMAKER IN THE POCKET. THE LEAD FOLLOWED A VERY SHARP ANGLE OF ENTRY INTO THE SUPERIOR VENA CAVA (SVC) WHICH WAS QUITE VISIBLE ON THE CHEST X-RAY. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE. A REPLACEMENT LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 4517| H125| (B)(4)| 4473| (B)(4)| 6990| 4087| 4088| (B)(4)| MISMATCH