BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905652 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11465
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 1, 2013
    Report Date
    May 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. ALL OTHER LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS AND THERE WAS NO NOISE PRESENT ON THE RV CHANNEL. THE PATIENT IS NOT PACEMAKER DEPENDENT AND HAS NOT EXPERIENCED ANY ADVERSE PATIENT EFFECTS. THE PHYSICIAN SUSPECTED A PROBLEM WITH CALCIFICATION OF THE LEAD TIP. A SAVE ALL TO DISK WAS SENT IN FOR TECHNICAL ANALYSIS. ALL OF THE RV IMPEDANCE VALUES HAVE BEEN SATURATED FOR OVER A YEAR. THIS PRODUCT REMAINS IN-SERVICE. THE DATA DISK CONFIRMED THAT THE PACE IMPEDANCES WERE SATURATED; HOWEVER ALL OTHER LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS. THE FIELD REPRESENTATIVE WILL COMMUNICATE RESULTS WITH THE PHYSICIAN AND THE PATIENT WILL BE PLACED ON A REMOTE MONITORING SYSTEM TO CONTINUE TO MONITOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384541 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 F102| 0175