BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3212434 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09160
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD NO PACING OUTPUT AND NO TELEMETRY TRANSMISSIONS. SEVERAL HIGH LEVEL ENGINEERING TESTS WERE PERFORMED TO ASSESS THE ANOMALY. AN EXTERNAL POWER SUPPLY WAS CONNECTED WHICH REVEALED A HIGH CURRENT DRAIN. THE DEVICE CASE WAS OPENED AND THE MIXED MODE INTEGRATED CIRCUIT (MMIC) WAS ISOLATED. HIGH POWERED VISUAL INSPECTION REVEALED DAMAGE TO THE SURFACE OF THE MMIC AND ELECTRICAL RUNS. THE LOCATION OF THE DAMAGE WAS IN A PORTION OF THE CIRCUITRY THAT CONTROLLED THE TELEMETRY FOR THE DEVICE. FINAL ANALYSIS CONCLUDED THIS DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE WAS HOSPITALIZED. UPON PRESENTATION IT WAS NOTED THEIR RHYTHM WAS COMPLETE HEART BLOCK WITH A RATE OF THIRTY BEATS PER MINUTE. THIS DEVICE COULD NOT BE INTERROGATED AND THERE WAS NO RESPONSE FROM THE DEVICE. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. AN URGENT REPLACEMENT WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    - -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312658 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S401

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R