BEUDAMED
    FDA Adverse Event Summary report: N

    ST. JUDE MEDICAL ATLAS+ DR V-243

    MDR report key: 3042782 · Received April 3, 2013

    Report

    Report Number
    MW5029655
    Date Received
    April 3, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ST. JUDE MEDICAL INC.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A FINAL OF TWO DEFIBRILLATION THRESHOLD TESTS, THERE WAS A DEVICE FAILURE OF THE ICD LEAD CAUSING PRESUMPTIVE SHORT-CIRCUIT OF THE ICD GENERATOR, WHICH REVERTED TO A BACKUP SAFETY PACING MODE. PT REQUIRED EXTERNAL RESCUE TO BE STABILIZED. FLUOROSCOPY PERFORMED OF ENTIRE SYSTEM, ATTENTION PAID TO INTRA-CARDIAC PORTION OF LEADS. MULTIPLE ANGULATIONS VIEWED. COMPLETE DEVICE PROGRAMMING EVAL PERFORMED, INCLUDE REVIEW OF DEVICE LOGS, INTERACTIVE TESTING OF PACING AND SENSING THRESHOLDS, AND MEASUREMENT OF LEAD IMPEDANCES. DFT TEST PERFORMED USING SHOCK-ON-T INDUCTION OF VENTRICULAR FIBRILLATION. AFTER SECOND TEST, DEVICE COULD NOT BE INTERROGATED, REVERTED TO BACKUP OF VVI AT 60 BPM, AT MAX OUTPUT. OF NOTE, LOW ENERGY SHOCKS WERE DELIVERED PRIOR TO EACH DFT TEST TO CONFIRM STABLE SHOCK COIL IMPEDANCE. PT REQUIRED TO UNDERGO DEVICE EXTRACTION ONE WEEK FOLLOWING. CURRENTLY TREATED WITH COUMADIN AND SOTALOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136389 ST. JUDE MEDICAL ATLAS+ DR V-243 ICD GENERATOR NIK ST. JUDE MEDICAL INC. ATLAS+ DR V-243
    136390 ST. JUDE MEDICAL ICD LEAD ICD LEAD LWS ST. JUDE MEDICAL INC. *RIATA 1580* -65CM

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R