BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050136 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03829
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED. THE INSULATION WAS CUT THROUGH TO THE RS- LUMEN AT 332MM FROM THE TERMINAL PIN. THE HELIX WAS EXTENDED, INTACT, AND UNDAMAGED. THERE WAS BLOOD/BODY FLUID IN THE RS- LUMEN DUE TO THE CUT IN THE INSULATION AND THERE WAS ALSO BLOOD/BODY FLUID IN THE HELIX HOUSING. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE EXTENDABLE/RETRACTABLE HELIX LEAD IS SUSCEPTIBLE TO BLOOD INFILTRATION, AND MAY CAUSE IRREGULARITIES IN THE EXTENSION OR RETRACTION OF THE HELIX. THE LEAD DISLODGEMENT COULD NOT BE CONFIRMED THROUGH ANALYSIS. THE OBSERVATION THAT THE HELIX WOULD NOT RETRACT WAS CONFIRMED AND LIKELY THE ROOT CAUSE WAS BLOOD CLOGGING IN THE HELIX MECHANISM.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUTS THE DAY POST IMPLANT. THE PATIENT'S UNDERLYING RHYTHM WAS SINUS BRADYCARDIA AT 55BPM. IT WAS DETERMINED THE LEAD WAS MICRO-DISLODGED. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS EXPLANTED AS THE HELIX WOULD NOT RETRACT. ANOTHER RV LEAD WAS SUCCESSFULLY PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152795 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 4542| 0295| 4136| N140| 4473