BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2170088 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09784
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED MOLDED NECK INSULATION BETWEEN HELIX HOUSING AND MOLDED NECK SEPARATION FROM THE ANODE RING. THIS SEPARATION MAY HAVE BEEN A RESULT OF DAMAGE SUSTAINED AT THE EXPLANT PROCEDURE. THE DISTAL RING SHOWED SIGNS OF A CLOCKWISE TWIST, WHICH IS INDICATIVE OF OVER-TORQUE OF THE HELIX. THE HELIX WAS IN THE EXTENDED POSITIONED WHEN RECEIVED. THE LEAD WAS DETERMINED TO HAVE BEEN ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATION WAS NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    THE LEAD HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED. A LEAD REVISION PROCEDURE WAS PERFORMED WHERE THE LEAD WAS ATTEMPTED TO BE REPOSITIONED. THE HELIX WAS STUCK EXTENDED AND THE LEAD WAS NOT ABLE TO BE REPOSITIONED. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LEAD IS TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 4469| 4086| E110| 0137