BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4149533 · Received October 7, 2014

    Report

    Report Number
    2124215-2014-15894
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    August 3, 2014
    Report Date
    January 14, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DETAILS WERE RECEIVED NINE MONTHS AFTER THE INITIAL OBSERVATIONS WERE REPORTED STATING THAT SHOCKING IMPEDANCE WAS STILL HIGH AND WAS CURRENTLY AT 155 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER WHO STATED THEY WILL CONTINUE TO MONITOR THIS PATIENT FOR NOW. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL DETAILS ARE RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS WERE RECEIVED THAT THE SHOCKING IMPEDANCE HAS CONTINUED TO RISE AND WAS 175 OHMS. THE PHYSICIAN TESTED DIFFERENT VECTORS AND ALL VECTORS PRODUCED HIGH IMPEDANCE. THE PATIENT HASN'T HAD ANY EPISODES AND THE PHYSICIAN DECIDED TO PROGRAM THE DEVICE TO MONITOR ONLY (MO) MODE DUE TO THE PATIENT'S IMPROVED EJECTION FRACTION (EF). THE PATIENT WAS AGREEABLE AND DIDN'T WANT TO UNDERGO ANOTHER PROCEDURE WHICH WOULD INVOLVE A LEAD EXTRACTION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. THIS DEVICE AND LEAD REMAINS IN SERVICE. 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
    626988 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR H217| N119| 5076| 4542| H210