BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 3061782 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06296
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    November 7, 2012
    Report Date
    March 27, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED SEVERED. DETAILED ANALYSIS INSULATION ABRASION NOTED ON THE IS-1 TERMINAL LEG THROUGH TO THE RS+ CONDUCTOR COIL 52-60MM FROM THE TERMINAL PIN. BOTH THE INSULATION AND INSULATION SLEEVE ARE ABRADED THROUGH. THERE ARE MULTIPLE DEEP SURFACE ABRASIONS ON ALL THREE TERMINAL LEGS, BUT ONLY THIS PORTION IS ABRADED THROUGH. AT THE ABRASION LOCATION THERE ARE TWO ABRASIONS THAT OVERLAPPED EACH OTHER. IT APPEARS THERE WAS A LEAD-ON-LEAD ABRASION, AND ALSO A LEAD-ON-LEAD OR POSSIBLE LEAD-ON-CAN ABRASION RIGHT NEXT TO IT/CROSSING OVER IT. ONE PORTION OF THE ABRASION IS SMOOTH AND A PART OF THE ABRASION IS JAGGED, AND MARKS FROM THE UNDERLYING COILS CAN BE SEEN IN THE INSULATION INNER CIRCUMFERENCE. MELTED METAL IS EVIDENT ON THE RS+ CONDUCTOR COIL UNDERNEATH THIS ABRASION SITE. TWO OF THE FOUR RS+ CONDUCTOR COIL FILARS ARE DISCONTINUOUS IN THIS AREA. FURTHER ANALYSIS NOTED THAT THE INSULATION ABRASION ALSO NOTED 150-160MM FROM THE TERMINAL PIN THROUGH TO THE DISTAL AND PROXIMAL HV LUMENS. THE GORE ON BOTH DBS CABLES APPEARS INTACT. THE ABRASION IS SMOOTH AND TENDS TO SPIRAL AROUND THE LEAD. THE MORPHOLOGY OF THE INSULATION BREACH IS INDICATIVE OF LEAD-ON-LEAD CONTACT. LABORATORY ANALYSIS CONCLUDED THAT THERE WAS INSULATION ABRASION THROUGH THE RS+CONDUCTOR COIL ON THE IS-1 LEG. IT WAS NOTED THAT INSULATION ABRASION THROUGH TO AN EXPOSING A SENSING CONDUCTOR COIL COULD CAUSE NOISE. IN ADDITION, IT WAS CONFIRMED THAT THE IS-1 ID TAG WAS RETURNED CRACKED IN TWO AND THAT THE EDGE HAS CUT THROUGH THE INSULATION FROM MOVEMENT, THIS DAMAGE IS THROUGH TO THE RS+ CONDUCTOR COIL AND ALSO COULD HAVE CAUSED NOISE SEEN BY THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS NOTED ON THIS RIGHT VENTRICULAR LEAD. THIS PATIENT WAS HOSPITALIZED FOR A REVISION PROCEDURE. A PART OF THIS LEAD WAS REMOVED WHILE THE REST OF THE LEAD WAS SURGICALLY ABANDONED. THE EXPLANTED PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162380 ENDOTAK DSP IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 0048| T175| 0125| 1741| 6836| 0181