BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1952806 · Received January 7, 2011

    Report

    Report Number
    2124215-2011-00306
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    March 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. ANALYSIS OF THE REAL TIME CLOCK NOTED THAT IT LOST TIME. THE BATTERY STATUS ON THE DAY OF EXPLANT WAS END OF LIFE (EOL). ALTRUA LONGEVITY CALCULATIONS NOTED A NOMINAL LONGEVITY OF 5.3 YEARS. THE DEVICE DECLARED ELECTIVE REPLACEMENT TIME (ERT) IN 5.0 YEARS, OR 94% OF THE NOMINAL LONGEVITY. HIGH POWER VISUAL INSPECTION OF THE HEADER AND LEAD BARRELS NOTED NO IRREGULARITIES. THE DEVICE WAS PUT THROUGH AND PASSED THE RETURNED PRODUCTS TEST. THIS INVOLVES A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. THE CLINICAL OBSERVATION OF HIGH RATE PACING IS CAUSED BY INTERACTIONS BETWEEN THE DEVICE AND HOSPITAL MONITORING OR DIAGNOSTIC EQUIPMENT WHEN THE MINUTE VENTILATION (MV) FEATURE IS PROGRAMMED ON.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT SUSPECTED THAT THE MAGNET MAY HAVE MOVED AND THERE WAS OVERSENSING OF THE ELECTROCAUTERY USED TO THE SURGERY. THE DEVICE REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION AND WAS RETURNED FOR TESTING. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A MEDICAL PROCEDURE, A RATE OF 120PPM WAS BEING DELIVERED BY THIS PACEMAKER. THE PATIENT STARTED TO DECOMPENSATE AND A MAGNET WAS APPLIED TO THE DEVICE TO FORCE A PACED RATE OF 100 PPM. THE MINUTE VENTILATION (MV) AND ACCELEROMETER (XL) DEVICE FEATURES WERE THEN PROGRAMMED OFF AND THE PATIENT'S RATE DECREASED TO 30 BPM. THE CALLER WAS INQUIRING AS TO REASON FOR THE CLINICAL OBSERVATIONS.

    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 89 YR 4269| 1283| S603| 1273| 4285