BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952576 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23633
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD NOTED A TRACE OF TISSUE ON THE HELIX MECHANISM. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS, INDICATING THE LEAD WAS NOT FRACTURED.

    Additional Manufacturer Narrative · 1

    A NEW COMPETITOR RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, THE ATTEMPTED LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE; THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS ATTEMPTED TO BE POSITIONED APPROPRIATELY MULTIPLE TIMES. PACING IMPEDANCE MEASUREMENTS WERE UP TO 1700 OHMS AND THRESHOLDS MEASUREMENTS WERE UNACCEPTABLE. AFTER MULTIPLE ATTEMPTS TO POSITION THE LEAD; THE PATIENT EXPERIENCED CHEST PAIN AND A DROP IN BLOOD PRESSURE. THE PATIENT RECEIVED ATROPINE AND DOPAMINE INTRAVENOUSLY. THE MEDICATION HELPED STABILIZE THE BLOOD PRESSURE. THE DECISION WAS MADE TO REMOVE AND REPLACE THE LEAD WITH A COMPETITOR PRODUCT. THE IMPENDENCE AND THRESHOLD WERE SLIGHTLY IMPROVED. AN ECHOCARDIOGRAM WAS PERFORMED AFTER THE PROCEDURE AND REVEALED A PERICARDIAL EFFUSION. THE PACING SYSTEM REMAINS IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ATTEMPTED LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    --

    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 Life Threatening