BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1953841 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24667
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUT POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION OF THE DEVICE NOTED CORING OUT OF THREE SEAL PLUGS. NO OTHER VISIBLE ANOMALIES WERE NOTED. ATTEMPTS TO ESTABLISH TELEMETRY WERE UNSUCCESSFUL. AS TELEMETRY COULD NOT BE ESTABLISHED, LABORATORY ANALYSIS COULD NOT CONFIRM THE REPORTED RESET. THE DEVICE CASE WAS OPENED AND ELECTRICAL MEASUREMENTS OF INTERNAL CIRCUITRY NOTED A HIGH CURRENT CONDITION. THE HIGH CURRENT CONDITION WAS ISOLATED TO AN INTEGRATED CIRCUIT (IC). HIGH POWERED VISUAL INSPECTION OF THE IC REVEALED DAMAGE TO THE SURFACE OF THE IC AND ELECTRICAL RUNS. THE LOCATION OF THE SCRATCHES WERE IN A PORTION OF THE CIRCUITRY THAT CONTROLLED TELEMETRY, CONSISTENT WITH THE LAB OBSERVATION OF NO TELEMETRY. FINAL ANALYSIS CONCLUDED THIS DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS, AND THE CLINICAL OBSERVATION OF A RESET STATE WAS MOST LIKELY DUE TO THE OBSERVED IC DAMAGE. CORRECTIVE ACTION HAS BEEN IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, UPON INTERROGATION, THIS DEVICE INDICATED IT HAD RESET, AND DISPLAYED ERROR CODE 01. A COPY OF DEVICE MEMORY WAS SENT TO ENGINEERING FOR EVALUATION. ENGINEERING ANALYSIS OF MEMORY NOTED THE DEVICE HAD 75 RESETS. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANTS ADVISED THE DEVICE SHOULD BE EXPLANTED IF AN EXTERNAL CAUSE OF THE RESETS WERE NOT FOUND. THE DEVICE WAS LATER EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention