BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3041055 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01765
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD (B)(4) WAS TO BE RETURNED FOR BEING ANALYZED. UPON RECEIPT THIS LEAD WILL UNDERGO DETAILED ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TEST FOUND THE HELIX MECHANISM TEST HAD FAILED AND PASSED ALL OTHER ELECTRICAL MERRIMENT TESTING. MICROSCOPIC INSPECTIONS OF THE LEAD BODY, ELECTRODE TIP AND TERMINAL PIN ASSEMBLY FOUND SETSCREW MARK ON THE PIN AND DRAG MARKS ON THE TERMINAL RING. IN ADDITION, DRIED BLOOD WAS NOTED ON THE HELIX HOUSING. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATION OF LEAD DISLODGMENT AND DETAILED ANALYSIS COULD NOT CONFIRM THIS THROUGH TESTING. NO IRREGULARITIES WERE NOTED ON THE TIP SECTION OF LEAD THAT COULD CONTRIBUTE TO DISLODGMENT. IN CONCLUSION, AS OBSERVED IN THE LAB THE EXTENDABLE/RETRACTABLE HELIX LEAD WAS SUSCEPTIBLE TO BLOOD INFILTRATION. ONCE THIS HAS OCCURRED, EXTENSION/RETRACTION OF HELIX MAY NO LONGER BE SMOOTH - IRREGULARITIES SUCH AS STICKY, HESITANT, STOP-AND-GO EFFECT, JERKY, SPRING-IN, SPRING-OUT IS LIKELY TO OCCUR, OR IN SOME CASES THE MECHANISM COULD CEASE TO FUNCTION. THE LEAD WAS ARCHIVED AT BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS RIGHT ATRIAL (RA) LEAD EXHIBITING HIGH PACING IMPEDANCES WITH AN UNKNOWN RANGE. DUE TO THE HIGH IMPEDANCES THE PHYSICIAN ELECTED TO PERFORM A REVISION PROCEDURE. DURING THE REVISION THE PHYSICIAN FOUND THE RA LEAD TO HAVE DISLODGED. ATTEMPTS WERE MADE TO REPOSITION THE LEAD, HOWEVER THE HELIX DID NOT APPEAR TO BE WORKING. THE DECISION WAS MADE TO EXPLANT AND REPLACE THE LEAD. A NEW RA LEAD WAS SUCCESSFULLY IMPLANTED.NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142785 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4096| 0295| P142| 4549