BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1952514 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23395
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    June 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    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 POST MARKET QUALITY ASSURANCE 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. DURING THE INVESTIGATION OF THE FIELD ALLEGATIONS DAILY MEASUREMENTS TABLES IN THIS DEVICE DISPLAYED AUTOMATIC THRESHOLD VALUES AFTER ELECTIVE REPLACEMENT TIME (ERT) WAS DECLARED. THRESHOLD MEASUREMENTS ARE NORMALLY SUSPENDED POST-ERT, AND SHOULD BE DISPLAYED AS "NOT RECORDED". THIS OBSERVATION IS UNRELATED AND INCIDENTAL TO THE STATED REASON FOR RETURN. THE MEMORY DOWNLOAD AND PRINTOUTS WERE REVIEWED IN DETAIL AND NO SPECIFIC ROOT CAUSE FOR THE DISPLAY OF AUTOMATIC THRESHOLD VALUES POST-ERT COULD BE DETERMINED. A SAFETY RISK ASSESSMENT WAS CONDUCTED AND IT WAS DETERMINED THAT NEITHER THE SEVERITY NOR THE LIKELIHOOD OF THIS ISSUE WOULD REPRESENT AN INCREASED SAFETY RISK.

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR (PG) HAD HIGH THRESHOLDS AND PREMATURE BATTERY DEPLETION WAS ALLEGED. THE DEVICE WAS 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