BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041148 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01638
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL BE RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTIONS NOTED DRIED BLOOD IN HELIX AND HELIX HOUSING. NO IRREGULARITIES WERE NOTED AT THE TIP REGION OF THE LEAD. RESISTANCE AND PRESSURE TESTING WERE PERFORMED TO ASSESS THE ELECTRICAL CONTINUITY AND INSULATION INTEGRITY OF THE LEAD. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. FINAL ANALYSIS COULD NOT CONFIRM THE ALLEGATION OF DISLODGEMENT AS NO IRREGULARITIES WERE NOTED AT THE TIP SECTION OF THE LEAD OR WITH THE HELIX THAT COULD CONTRIBUTE TO DISLODGMENT. FINAL ANALYSIS CONFIRMED THE ISSUES OBSERVED CLINICALLY WITH THE HELIX MECHANISM AS THE BLOOD IN THE HELIX MECHANISM MOST LIKELY CONTRIBUTED TO EXTENSION/RETRACTION DIFFICULTY. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR TESTING AND IS CURRENTLY BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD BEEN EXHIBITING DECREASED R-WAVE MEASUREMENTS, INCREASED THRESHOLD MEASUREMENTS AND WAS FOUND TO HAVE MICRO-DISLODGED. THEREFORE, A REVISION PROCEDURE WAS PERFORMED. HOWEVER, DIFFICULTY WAS EXPERIENCED EXTENDING AND RETRACTING THE HELIX. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143129 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization E051| 0181| 0185| T180| 0180