BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2777104 · Received October 9, 2012

    Report

    Report Number
    2124215-2012-11101
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    July 27, 2012
    Report Date
    May 4, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED NEARLY TWO YEARS AFTER THE INITIAL OBSERVATIONS THAT THE RED ALERTS WERE STILL BEING GENERATED FOR THIS SYSTEM. A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS REMOVED FROM SERVICE AND REPLACED. THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINCIAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED STATING A FRACTURE OF THIS LEAD HAD BEEN SUSPECTED DUE TO THE OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS AND A HAD SHOCK DELIVERY DUE TO AN OPEN CONDITION. THE CALLER WAS INQUIRING ABOUT WARRANTY. THE FRACTURE WAS NOT CONFIRMED BUT THE CALLER STATED THAT THE BEHAVIOR INDICATED A POTENTIAL FRACTURE AND THEY WANTED WARRANTY CREDIT TO BE PROCESSED. WARRANTY CREDIT WAS ISSUED FOR THE LEAD. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL DETAILS ARE RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH SHOCK IMPEDANCES OF GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED CHECKING THE SHOCK IMPEDANCS IN ALL SHOCKING VECTORS, AND PERFORMING POCKET MANIPULATIONS AND SAMPLE IMPEDANCES. THEY NOTED THE THE BEST TEST FOR THE SYSTEM WAS TO PERFORM A 1.1 JOULE SYNCRHONIZED SHOCK AND A MAXIMUM ENERGY SYNCHRONIZED SHOCK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L E161| T175| 0184