BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921791 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12172
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    August 1, 2013
    Report Date
    May 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    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 THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE OF 0 OHMS. THE LOW OOR IMPEDANCE WAS NOTED THREE TIMES, TWICE LAST YEAR AND LAST MONTH. FURTHER, THE DEVICE WAS INTERROGATED RECENTLY AND ALL IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE. THE FIELD REPRESENTATIVE STATED TO CONTINUE TO MONITOR PATIENT. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS UNDETERMINED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400374 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 0184| 4554| 5076| N119| 4548