BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1042140 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34515
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 17, 2008
    Report Date
    April 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z0187-94/6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TS DISCUSSED BEAT TO BEAT VARIATION COUNTER AND SUGGESTED RATE SMOOTHING TO REDUCE VARIATION FROM 30% TO SOMETHING SMALLER. TS DISCUSSED PATIENT TRIGGERED ELECTROGRAMS TO OBTAIN PACING DATA DURING THE SYMPTOMS. THE SR STATED THE PATIENT PASSES OUT WITHOUT WARNING IS NOT SURE IF THIS COULD BE NEUROCARDIOGENIC SYNCOPE. TS SUGGESTED TURNING SUDDEN BRADY RESPONSE (SBR) ON AND RECOMMENDED A HOLTER MONITOR TO CATCH THE PATIENT'S HEART RATE DATA DURING THE EPISODES. AFTER THE PATIENT FOLLOW UP, THE SR INDICATED THE DEVICE WAS PROGRAMMED WITH THE SUDDEN BRADY RESPONSE (SBR) FEATURE ON AND THE VENTRICULAR TACHYCARDIA RATE WAS LOWERED TO 135BPM. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO OUR COMPANY, THE EVENT WILL BE UPDATED AS NECESSARY. THREE YEARS LATER THE DEVICE WAS EXPLANTED FOR AN UNSPECIFIED REASON AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC DEVICE. A REQUEST TO HAVE THE DEVICE RETURNED FOR ANALYSIS HAS BEEN MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THIS PATIENT HAS BEEN COMPLAINING OF SYNCOPAL EPISODES. THE PATIENT IS PACED IN THE ATRIUM 7% OF THE TIME AND IS REPORTED TO HAVE ATRIAL PACING AND VENTRICULAR SENSING AT 50BPM. THE SR NOTED THE ATRIAL SENSED RATES WILL INCREASE TO 120BPM. THE PATIENT WAS PREVIOUSLY PROGRAMMED TO DDD MODE AT 50BPM. AS OF THIS DATE, ALL PRODUCTS REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R THE DEVICE 4301/100159 WAS IMPLANTED 10-MAR-2005| THE DEVICE 4301/(B)(4) WAS IMPLANTED (B)(6)| THE DEVICE 4302/(B)(4) WAS IMPLANTED (B)(6)| THE DEVICE 4302/100270 WAS IMPLANTED 10-MAR-2005