BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2153408 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06485
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 8, 2011
    Report Date
    August 16, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST WAS MADE FOR THE PRODUCT RETURN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED. INVESTIGATION IS COMPLETE TO DATE.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR QUALITY ASSURANCE LABORATORY THE DEVICE UNDERWENT DETAILED ANALYSIS. VISUAL OBSERVATIONS NOTED NO ABNORMALITIES. ANALYSIS OF THE DATA IN DEVICE MEMORY SHOWED NO IRREGULARITIES TO CONTRIBUTE TO THE ALLEGATION. NO HIGHER THAN NORMAL CURRENT DRAIN CONDITIONS WERE NOTED DURING TESTING AND DETAILED ANALYSIS. IT IS CONCLUDED THAT THE DEVICE MEETS SPECIFICATIONS FOR NORMAL BATTERY DEPLETION. THE REASON FOR THE NO OUTPUT AND NO TELEMETRY CONDITION WAS CONCLUDED TO BE A NORMALLY DEPLETED BATTERY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER WAS ADMITTED FOR A REPLACEMENT. THE PATIENT PRESENTED TO THE EMERGENCY ROOM, REASON NOT DISCLOSED. THE PATIENT'S HEART RATE WAS 37 BEATS PER MINUTE. THE DEVICE COULD NOT BE INTERROGATED AND THERE WAS NO MAGNET RESPONSE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention 4086| 4088| 1298