BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4884355 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07268
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 20, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT ACCESSED THE DATA FROM THE REMOTE MONITORING SYSTEM AND THERE WERE THREE OUT OF RANGE(OOR) MEASUREMENTS ON THE SAME DAY AT THE SAME TIME. THE CONSULTANT EXPLAINED IT IS LIKELY RELATED TO THE PATIENT BEING IN AN ELECTROMAGNETIC INTERFERENCE (EMI) FIELD AT THE TIME OF THE DAILY MEASUREMENTS. THE CONSULTANT AND THE CALLER DISCUSSED THE PATIENT COULD PERFORM A PATIENT INITIATED INTERROGATION (PII) WITH A DAY OR TWO AND THEY WILL BE ABLE TO SEE THE OOR MEASUREMENTS AND THE FOLLOW-UP MEASUREMENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL DETAILS ARE RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS GENERATED FOR THIS SYSTEM DUE TO SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426221 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR N141| E110| 1488T| 0184| T125| 4543