BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132360 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14870
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2008
    Report Date
    July 21, 2014
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN DAILY SHOCK IMPEDANCE MEASUREMENTS UP TO 84 OHMS. THE AVERAGE DAILY MEASUREMENT WAS AROUND 70 OHMS. THE PHYSICIAN BELIEVED THE INCREASE WAS RELATED TO A MEDICATION THE PATIENT HAD BEEN ADMINISTERED. YEARS LATER, IT WAS REPORTED THAT THE DURING A ROUTINE FOLLOW-UP THE DEVICE HAD HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE LEAD WAS CONNECTED TO A COMPETITOR'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN HAS DECIDED TO CONTINUE TO FOLLOW THIS PATIENT AND NO FURTHER ACTION WILL BE PERFORMED AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612234 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0128

    Patients

    Seq Age Sex Outcome Treatment
    1 1860| 0128