BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043205 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01809
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER. IT WAS REPORTED THAT SINCE THE PATIENT HAS GOOD INTRINSIC CONDUCTION, THE PHYSICIAN ELECTED TO REPROGRAM THE DEVICE TO DDI-45PPM. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FROM THIS LEAD DUE TO LOW SENSING MEASUREMENTS. R-WAVE MEASUREMENTS AT IMPLANT WERE 10MV AND ARE CURRENTLY 1.5MV. ADDITIONALLY, THERE IS NO CAPTURE AT MAXIMUM DEVICE OUTPUT AND LEAD DISLODGEMENT IS SUSPECTED. ATRIAL NOISE WAS ALSO NOTED AND THE PATIENT WAS SHORT OF BREATH, POSSIBLY DUE TO LOSS OF AV SYNCHRONY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146555 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR H210| 0185| 0184| N119| 4087| 4543