BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6261407 · Received January 18, 2017

    Report

    Report Number
    2124215-2017-00664
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE NOISE AND LOW R-WAVES REMAINS UNKNOWN, THUS ADDITIONAL INFORMATION WAS REQUESTED. AT THIS TIME, THE PRODUCT REMAINS IN-SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS INTERMITTENT NOISE ON RIGHT VENTRICULAR (RV) LEAD CHANNEL. THE R-WAVES WERE LOW, BUT CONSISTENT WITH PREVIOUS CHECK. NO FURTHER INFORMATION WAS AVAILABLE. LEAD REMAINS IN-SERVICE. NAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43762 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 0185| 4087| 4470| E110| T165