BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905720 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11236
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 23, 2013
    Report Date
    May 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    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 REMOTE MONITORING OF THIS DEVICE AND RIGHT VENTRICULAR LEAD REVEALED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT. THIS INFORMATION HAS BEEN PROVIDED TO THE PHYSICIAN AND IS BEING FURTHER MONITORED. ALL OTHER MEASUREMENTS WERE NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. APPROXIMATELY, ONE YEAR LATER, A REPLACEMENT PROCEDURE WAS PERFORMED. THE RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO NOISE AND THE OUT OF RANGE IMPEDANCE MEASUREMENT. IN ADDITION, INCREASED THRESHOLD MEASUREMENTS WERE OBSERVED. THE PATIENT HAS NOT RECEIVED ANY INAPPROPRIATE SHOCKS. NO PACING INHIBITION WAS REPORTED AS A RESULT OF THIS ISSUE AS THE PATIENT IS PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384664 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0185| F102