BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162600 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07634
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 10, 2011
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE COMPLETE LEAD WAS RETURNED WITH A SET SCREW MARK NOTED ON ALL TERMINAL CONNECTORS. DURING TESTING THE HELIX MECHANISM WOULD NOT EXTEND DUE TO DRIED BLOOD IN MECHANISM. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE LEAD'S ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH OVERSENSING AND PACING INHIBITION. IT WAS NOTED THAT THE SENSING ON THE LEAD HAS BEEN DECREASING OVER THE LAST YEAR. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A LEAD REVISION PROCEDURE. THE RV LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO INAPPROPRIATE THERAPY OCCURRED DUE TO THE NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD REVISION PROCEDURE.

    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 77 YR Hospitalization| L| R 0185| 4518| 1298| 4456| 4469| N118