BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1953993 · Received January 21, 2011

    Report

    Report Number
    2124215-2010-24134
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 14, 2010
    Report Date
    February 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REMOVED AND RETURNED FOR ANALYSIS. ANALYSIS CONCLUDED THE DEVICE HAD NOT REACHED ELECTIVE REPLACEMENT INDICATORS. THE DEVICE WAS SUBJECTED TO SIMULATED HEART LOAD CONDITIONS AND THE PACING AND SENSING FUNCTIONS WERE ANALYZED. NO ANOMALIES WERE REVEALED. ANALYSIS CONCLUDED THIS DEVICE MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMAITON BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION IS OBTAINED, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, IT WAS NOTED THIS DEVICE WAS PROTRUDING THROUGH THE PATIENT'S SKIN. A REVISION PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED ON THE OPPOSITE BODY SIDE. IN ADDITION, THE CHRONIC RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED AND ALSO REPLACED ON THE OPPOSITE BODY SIDE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S508

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 0476| (B)(4)| S508