BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 1946176 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20770
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. A COMPLETE LEAD WAS RECEIVED WITH SETSCREW MARKS NOTED ON BOTH TERMINAL PINS. INSULATION CUTS WERE OBSERVED 268-273MM FROM THE TERMINAL PIN WITH DRIED BLOOD IN AND AROUND THE HELIX HOUSING. ENGINEERS ALSO CONFIRMED THE HELIX COIL HAD BECOME EXTREMELY STRETCHED. EXTENSIVE TESTING WAS THEN PERFORMED TO ASSESS THE LEAD'S ELECTRICAL INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WAS NO INTERMITTENCY IN THE ELECTRICAL CONDUCTIVITY. WHILE LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION OF LEAD DISLODGMENT, A STRETCHED HELIX WAS VERIFIED.

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCT RETURN AND ANALYSIS, THIS REPORT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THE LEAD WAS RECEIVED FOR POST MARKET EVALUATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD DISLODGED. THE PHYSICIAN ATTEMPTED TO REPOSITION; HOWEVER EFFORTS WERE WITHOUT AVAIL AS THE HELIX HAD BEEN STRETCHED. AS A RESULT, THE PRODUCT WAS EXPLANTED AND IS INTENDED TO BE RETURNED FOR POST MARKET EVALUATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention