BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3963644 · Received July 29, 2014

    Report

    Report Number
    2124215-2014-14617
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VIA THE PATIENT REMOTE MONITORING SYSTEM THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE CAUSE OF THIS OBSERVATION WAS NOT DETERMINED. THE PATIENT WAS BROUGHT BACK TO THE OFFICE TO CHECK SHOCK IMPEDANCE AND FOUND IMPEDANCE TO BE NORMAL; CONTINUE OBSERVATION WAS PLANNED. AT THIS TIME, THE DEVICE AND LEADS REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441811 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4555| N141| 0185| 4136| H217