BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1950754 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22505
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    January 12, 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 AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED SEVERED APPROXIMATELY SEVEN CENTIMETERS FROM THE TERMINAL PIN. THE HELIX WAS INSPECTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE HELIX MECHANISM WAS UNABLE TO BE TESTED DUE TO THE LEAD BEING SEVERED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED ON EACH LEAD SEGMENT TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO OTHER ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS. OUTSIDE OF THIS LEAD BEING SEVERED, DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    ONCE THE LEAD HAS BEEN RETURNED AND ANALYZED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A LEAD REVISION WAS PERFORMED BUT THE HELIX WOULD NOT EXTEND DURING THE PROCEDURE. THIS LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH ANOTHER LEAD OF THE SAME MODEL. THE EXPLANTED LEAD WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 1793| 0145| T177