BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151698 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-05953
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING RETURN AND COMPLETION OF LAB ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THIS LEAD IDENTIFIED TWO DISTINCT AREAS OF INSULATION DAMAGE: ONE AREA 135-140 MM FROM THE TERMINAL PIN (CONSISTENT WITH LEAD-ON-LEAD CONTACT) AND ONE AREA 335 MM FROM THE TERMINAL PIN. RESISTANCE TESTING FOUND THAT THIS LEAD CONDUCTOR WAS DISCONTINUOUS. DETAILED TESTING OF THE LEAD FOUND THAT THE INSULATION ABRASION IN THE AREA 335 MM FROM THE TERMINAL PIN HAD EXPOSED THE RS- AND DISTAL HIGH VOLTAGE CONDUCTOR COILS. THE DISTAL HIGH VOLTAGE CABLE WAS COMPLETED ABRADED THROUGH AND ARCING DAMAGE WAS EVIDENT. THE DAMAGE APPEARS CONSISTENT WITH CLAVICULAR/FIRST RIB CRUSH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THESE LEADS RECEIVED AN INAPPROPRIATE SHOCK. DURING INTERROGATION, ELECTROGRAM NOISE, AS WELL AS A DECREASE IN SENSING AND PACING IMPEDANCES WERE OBSERVED. ADDITIONALLY, HIGH OUT OF RANGE SHOCK IMPEDANCES VALUES WERE NOTED. THE PHYSICIAN ATTRIBUTED ALL THESE CLINICAL OBSERVATIONS TO A SUBCLAVIAN CONDUCTOR FRACTURE AND EXPLANTED BOTH LEADS IN THE ABSENCE OF ADDITIONAL ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention