BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2053312 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04470
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 21, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. NO ISSUES WERE FOUND IN ANALYSIS. THE ALLEGATION WAS REPORTED APPROXIMATELY SIX YEARS PRIOR TO THE EXPLANT AND WAS ADDRESSED AT THAT TIME AND IDENTIFIED AS A LEAD ISSUE. NO ALLEGATIONS HAVE BEEN REPORTED SINCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS NON BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD WAS SENSING NOISE AND CAUSING PACING INHIBITION. SUBSEQUENTLY, THE LEAD WAS EXPLANTED AND REPLACED. THE PACEMAKER REMAINS IN SERVICE WITH NO FURTHER ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    PACEMAKER WAS EXPLANTED FOR NORMAL BATTERY DEPLETION IN (B)(6) 2017. NO CORRESPONDING ALLEGATIONS SINCE 2011 OR CLINICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S204

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR (B)(4)| (B)(4)| (B)(4)| MISMATCH| (B)(4)