BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2163123 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07109
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    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

    FOLLOWING RETURN TO BOSTON SCIENTIFIC, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED IN OUR (B)(4) LABORATORY. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY, RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS DEPICTED IN THE INSTRUCTIONS FOR USE THAT WERE ORIGINALLY APPROVED AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY ESTIMATION TOOLS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR WAS REMOVED FROM SERVICE WITHOUT ALLEGATION AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS PURPOSES. THERE WERE NO ADVERSE PATIENT SYMPTOMS, BEYOND THE SURGICAL INTERVENTION THAT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 1248 MO Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)