BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1945069 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20379
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, VISUAL INSPECTION OF THIS DEVICE NOTED NO ANOMALIES. THE DEVICE THEN UNDERWENT DIAGNOSTIC TESTING OF DEVICE FUNCTIONS AND MEMORY. THE RESULTS OF THE TESTS INDICATED THE DEVICE HAD MEMORY CORRUPTION, AND RESET PACING. HIGH RESOLUTION X-RAY OF THE DEVICE FOUND A BROKEN INTERNAL COMPONENT WITHIN THE ACCELEROMETER. ANALYSIS CONCLUDED THIS CONDUCTIVE COMPONENT CONTACTED ANOTHER INTERNAL COMPONENT, CAUSING THE REPORTED OBSERVATIONS. THE BROKEN COMPONENT WAS LIKELY A RESULT OF IMPACT SUSTAINED BY THE DEVICE. FURTHER ANALYSIS ALSO REVEALED A CRACKED INTERNAL COMPONENT WITHIN THE MINUTE VENTILATION (MV) SENSOR. ANALYSIS WAS UNABLE TO DETERMINE A ROOT CAUSE OF THE BROKEN COMPONENT'S. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED UPON SEVERAL ATTEMPTS. INTERMITTENT PACING AT A RATE OF 65 WAS REPORTED. A PACEMAKER REPLACEMENT PROCEDURE WAS PERFORMED WERE THIS DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R 1284| 4063| 4034| S403