BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1851220 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14111
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 18, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EXPLANTED AND RETURNED APPROXIMATELY FOUR YEARS LATER FOR AN UNSPECIFIED REASON. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE ELECTROCAUTERY MARKS IN THE HEADER, HOWEVER THIS WAS MOST LIKELY FROM THE EXPLANT PROCEDURE. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. TECHNICIANS NOTED THE EXPLANT DATE LISTED IN OUR RECORDS OF (B)(4) 2014 WAS NOT LIKELY AS THAT WAS THE PRIOR TO THE DEVICE BEING RECEIVED AT BOSTON SCIENTIFIC. BASED ON THE DEVICE MEMORY, THE LIKELY EXPLANT DATE WAS (B)(4) 2014 WHICH GIVES A TOTAL IMPLANT TIME OF 8.2 YEARS.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT FROM A MEDICAL PERSON THAT THIS PATIENT WAS IN THE HOSPITAL AND AN ELECTROCARDIOGRAM (EKG) SHOWED AN ATRIAL PACING SPIKE FOLLOWING BY A LONG PAUSE (400 MS), THEN AN INTRINISIC R-WAVE. THE CALLER STATED SOMETHING WAS WRONG WITH THE PACEMAKER AND SENT THE PATIENT TO THE CARDIOLOGY CLINIC TO BE SEEN. VENTRICULAR CAPTURE WAS 0.8V AT 0.5MS AND TODAY AT 1.6V AT 0.5MS SHOWING APVP, BUT SEEING A FUSION BEAT WITH NO LONG PAUSES. TECHNICAL SERVICES SUSPECTS LOSS OF CAPTURE AND FUSION. THE OUTPUTS WERE INCREASED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, HOWEVER THE PATIENT DID MENTION SHE WASN'T FEELING WELL. ALL OTHER MEASUREMENTS WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening 4034| 1291| 1283| 4063