BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1864151 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16035
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT > 2000 OHMS AND HIGH THRESHOLDS WAS DETECTED ON THIS DEFIBRILLATION LEAD. THERE WAS ALSO REPORT OF SMALL BASELINE NOISE. THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. RESOLUTION WAS REQUESTED FROM THE FIELD REPRESENTATIVE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE LEAD WAS NOT FULLY INSERTED THROUGH THE CONNECTOR BLOCK. THE SET SCREW WAS LOOSENED, THE LEAD TESTED ON THE PACING SYSTEM ANALYZER, AND REINSERTED INTO HEADER. IMPEDANCE WAS THEN 426 OHMS. FURTHER, UPON VISUAL INSPECTION OF THE 4470 THE OUTER LAYER OF INSULATION WAS FOUND TO BE CRACKED 1.5 TO 2 INCHES FROM THE PROXIMAL END OF THE LEAD. TECHNICAL SERVICES ADVISED NO WAY TO REPAIR AND THAT A NEW LEAD SHOULD BE IMPLANTED. THE PHYSICIAN CHOSE TO SURGICALLY ABANDON THIS LEAD AND REPLACE IT WITH A NON-BOSTON SCIENTIFIC LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention E110| T125| 4470| 0185| 0175| 5076