BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 4150847 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16860
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    January 1, 2011
    Report Date
    August 30, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUAL INCREASE IN PACING LEAD IMPEDANCE MEASUREMENT, THOUGH STILL WITHIN NORMAL RANGE. A FLUCTUATION IN PACING THRESHOLD WAS ALSO NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED X-RAY, ISOMETRICS AND EVALUATION OF THE SYSTEM IN UNIPOLAR CONFIGURATION; UNABLE TO RULE OUT A PROXIMAL CONDUCTOR ISSUE. TS THEN PROVIDED LEAD IMPEDANCE RANGE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THREE MONTHS LATER THIS SYSTEM EXHIBITED HIGH, OUT-OF-RANGE (OOR) PACING IMPEDANCE MEASUREMENT OF MORE THAN 2,000 OHMS. TS DISCUSSED TROUBLESHOOTING OPTIONS. SUBSEQUENTLY, THE SYSTEM CONFIGURATION WAS CHANGED TO UNIPOLAR AND IMPEDANCE MEASUREMENT DECREASED TO 860 OHMS. AT THIS TIME, NO FURTHER INTERVENTION WAS PERFORMED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632523 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4088| 4087| S603