BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1962283 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00981
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    August 6, 2010
    Report Date
    April 22, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PG REMAINS IMPLANTED AND THUS WILL NOT BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. MICROSCOPIC VISUAL INSPECTION FOUND THE RV LEAD TIP STILL IN THE RV PORT AND ALL THE SEAL PLUGS MISSING AND ALL BUT THE RA RING SETSCREW MISSING. THERE ARE SEAL PLUG MARKS ON THE HEADER INDICATING THE SEAL PLUGS WERE PRESENT WHILE IMPLANTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. 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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT THIS PATIENT IS BEING MONITORED AND A PROCEDURE WILL BE PLANNED IN THE FUTURE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT THIS DEVICE WAS EXPLANTED AND RETURNED. UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR (PG) DISPLAYED NOISE, OVERSENSING WHICH RESULTED IN PACING INHIBITION ON VENTRICULAR CHANNEL. THE PATIENT WAS ASYMPTOMATIC. FURTHER INVESTIGATION NOTED THAT PACING THRESHOLDS AND LEAD IMPEDANCES HAD INCREASED AND WERE OUT OF RANGE IN THE BIPOLAR CONFIGURATION. THE PG WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION. A BOSTON SCIENTIFIC REPRESENTATIVE INQUIRED ABOUT TECHNICAL ADVICE WHEN IT COMES TO PROGRAMMING OPTIONS FOR OPTIMIZATION FOR THIS PATIENT. TECHNICAL SERVICES DISCUSSED CURRENT PROGRAMMING AND NOTED THAT THE CLINICAL OBSERVATIONS MAY BE CAUSED BY INSULATION DEFECT OF THE OUTER CONDUCTION COIL OR FRACTURE OR A CONNECTION ISSUE. SUBSEQUENTLY AN X-RAY WAS TAKEN WHICH CONFIRMED THAT THE RIGHT VENTRICULAR LEAD (COMPETITOR) WAS NOT FULLY INSERTED. AT THIS TIME NO FURTHER ACTION HAS BEEN TAKEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S502

    Patients

    Seq Age Sex Outcome Treatment
    1 S502| 1646T| 1642T