BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210154 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07141
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS SCHEDULED FOR A FOLLOW-UP VISIT WITH THE CLINIC DUE TO THE OUT OF RANGE IMPEDANCE MEASUREMENT AND NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309877 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0184| 4086| 4542| H210