BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2040070 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00239
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THE HELIX WAS RETRACTED. RESISTANCE AND PRESSURE TESTING WERE PERFORMED TO ASSESS THIS LEADS ELECTRICAL AND INSULATION INTEGRITY. ANALYSIS REVEALED THESE MEASUREMENTS WERE WITHIN SPECIFICATION. THE HELIX FAILED TO RETRACT, LIKELY DUE TO DRIED BLOOD PRODUCTS THROUGHOUT THE HELIX MECHANISM. ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL ALLEGATION; ELECTRICALLY, THIS LEAD MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED THE HELIX WAS RETRACTED AND WITHIN SPECIFICATION. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE LEADS ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. DRIED BLOOD WAS NOTED THROUGHOUT THE HELIX MECHANISM. ANALYSIS CONCLUDED THE LEAD WAS ELECTRICALLY CONTINUOUS.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REVISION PROCEDURE WAS PERFORMED. THIS ATRIAL LEAD WAS NOT CAPTURING. AN X-RAY REVEALED THE LEAD HAD DISLODGED. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. 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 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention