BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1863606 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15523
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    January 24, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. THE REPORTED CLINICAL OBSERVATIONS FROM SIX YEARS AGO WERE UNABLE TO BE CONFIRMED OR DUPLICATED IN THE LABORATORY SETTING.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM STRIPS AND CONFIRMED THE ASYSTOLE OF 2 BEATS. TS SUGGESTED A FULL LEAD DIAGNOSTICS, CHEST X-RAY OF THE RV LEAD AND POCKET MANIPULATION WITH SETTING THE SENSITIVTY BACK TO 2.5MV TO TRY AND REPRODUCE THE ISSUE. AS OF THIS REPORT, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT TELEMETRY STRIPS WERE SHOWING INHIBITION OF PACING WITH TWO BEATS OF ASYSTOLE. THE PHYSICIAN WAS CONCERNED WITH A SET SCREW ISSUE AS RIGHT VENTRICULAR (RV) THRESHOLD AND IMPEDANCE MEASUREMENTS WERE STABLE, HOWEVER IT WAS NOTED THAT THE RV LEAD SLACK WAS PULLED TIGHT. RV SENSITIVITY SETTINGS WERE SET AT NOMINALS OF 2.5MV, THEREFORE REPROGRAMMED TO 10MV TO UNDERSENSE. THE PATIENT IS PACEMAKER DEPENDENT, HOWEVER NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY SIX YEARS LATER, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THERE HAVE BEEN NO ADDITIONAL ALLEGATIONS OR COMPLAINTS REPORTED SINCE THIS EVENT INITIALLY OCCURRED IN 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 4269| 1286| 4285| S603| 5076