BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053589 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05064
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A FOLLOW UP VISIT WAS PERFORMED. VENTRICULAR CHANNEL NOISE WAS OBSERVED. STIMULATION IMPEDANCE REMAINED HIGH OUT OF RANGE. THRESHOLDS WERE ALSO INCREASED. WHEN THE POCKET WAS MANEUVERED, NOISE COULD BE REPRODUCED. WHEN THE NOISE DISAPPEARED, NORMAL IMPEDANCE MEASUREMENTS WERE OBTAINED. A CONNECTION ISSUE IS SUSPECTED. A LEAD REVISION IS INTENDED, BUT NO SCHEDULED AS OF THIS DATE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. ISOMETRIC MANEUVERS INCLUDING ARM MOVEMENT AND POCKET HANDLING REVEALED NO NOISE COULD BE REPRODUCED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR REVIEW OF THE MEMORY DOWNLOAD. ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. ENGINEERING REVIEWED THE DATA AND DETERMINED THAT DURING THE OUT OF RANGE IMPEDANCE MEASUREMENTS, THE CIRCUITRY APPEARED TO BE OPEN. THE ELECTROGRAMS DID NOT REVEAL ANY NOISE INDICATING A CONNECTION ISSUE. FURTHER ISOMETRICS WERE RECOMMENDED. IN ADDITION, A HIGH RESOLUTION X-RAY WAS RECOMMENDED TO VERIFY THE CONNECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. FURTHER SIMILAR ALERTS HAVE BEEN RECEIVED. REPORTEDLY, THE PHYSICIAN HAS BEEN AWARE OF THESE INCREASED MEASUREMENTS SINCE IMPLANT. A REVISION PROCEDURE WAS SCHEDULED BUT WAS CANCELLED. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155020 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1