BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 3921997 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13636
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    February 7, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IMPEDANCE HAS BEEN HIGH BUT STABLE. HOWEVER, THE CAUSE WAS NOT DETERMINED AND THE PHYSICIAN WILL CONTINUE TO MONITOR. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT HIGH, OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. SUBSEQUENTLY, THE DEVICE HAS NOW BEEN PROGRAMMED TO MONITOR ONLY AND THE OOR ALERTS SHOULD NO LONGER BE SENT PER THE CLINIC AS THE DAILY MEASUREMENTS WILL BE TURNED OFF. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT HIGH, OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. THE PRESENTING ELECTROGRAM (EGM) INDICATED THE SHOCK CHANNEL WAS CLEAN AND DIDN'T EXHIBIT ANY NOISE. THE PHYSICIAN INQUIRED ABOUT REPROGRAMMING TACHY THERAPY BACK ON. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED THAT IF TACHY THERAPY WAS TURNED BACK ON THEY PERFORM A COMMANDED SHOCK TO TEST THE SYSTEMS ABILITY TO CHARGE AND DELIVER A SHOCK WITHOUT AN OPEN CIRCUIT CONDITION BEING DETECTED. SUBSEQUENTLY, TACHY THERAPY WAS NOT PROGRAMMED BACK AND THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401572 ENDOTAK RELIANCE G IMPLANTABLE DEFIBRILLATION LEAD LWS BOSTON SCIENTIFIC CORPORATION 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4047| H220| 4469| 4046| 0184| N161| 4548| 4470| 4591