BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1861069 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15284
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUT POST-MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THE DEVICE COULD NOT BE INTERROGATED WITH A PROGRAMMER. ENGINEERING TOOLS WERE USED TO ANALYZE DEVICE MEMORY. THE DEVICE HAD MULTIPLE RESETS MEMORY CORRUPTION. VISUAL INSPECTION NOTED NO DAMAGE TO THE DEVICE CASE OR HEADER. AN X-RAY OF THE DEVICE FOUND PART OF THE ACCELEROMETER HAD BROKEN. THE DAMAGED ACCELEROMETER PART WAS ISOLATED AND DEVICE SOFTWARE WAS RELOADED. THE DEVICE WAS ABLE TO PACE AND SENSE WITH THE ACCELEROMETER ISOLATED. ANALYSIS CONCLUDED THE BROKEN ACCELEROMETER PART MOST LIKELY CAUSED SHORT CIRCUITS IN THE DEVICE, LEADING TO RESETS AND MEMORY CORRUPTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAD NO TELEMETRY. IT WAS REPORTED THE DEVICE WAS PACING AT VVI 65, AND THE PATIENT HAD THIRD DEGREE HEART BLOCK AND HAD EXPERIENCED SYNCOPE. SEVERAL TROUBLESHOOTING ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT STATED THE DEVICE BEHAVIOUR WAS CONSISTENT WITH A POWER ON RESET. THE DEVICE WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S503

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R