BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE RIATA ICD LEAD

    MDR report key: 1839018 · Received September 14, 2010

    Report

    Report Number
    MW5017436
    Event Type
    Death
    Date Received
    September 14, 2010
    Date of Event
    June 8, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DECEASED RECEIVED ST. JUDE ICD ON (B)(6)2008. DEFIBRILLATOR EPIC + VR MODEL V-196, -50001690-001- (B)(4)-. ON (B)(6) AT APPROX. 6PM, PATIENT FAINTED AFTER JOGGING. ICD DID NOT DELIVER APPROPRIATE SHOCK THERAPY. EMS RESPONDED AFTER 15 MINUTES AND PERFORMED EXTERNAL DEFIBRILLATION AND HEART MASSAGE. SHE WAS TRANSPORTED TO HOSPITAL AND PRONOUNCED DEAD. ST. JUDE SENT FAMILY THE FOLLOWING REPORT. CUSTOMER INVESTIGATION SUMMARY CARDIAC RHYTHM MANAGEMENT DIVISION QUALITY ASSURANCE AND REGULATORY AFFAIRS, ST. JUDE MEDICAL AB, (B)(4) REPORT NO/REF NO: (B)(4), DEVICE: ICD LEAD, DATE: 2010-(B)(6). MODEL: V-196 EPIC+ VR ICD 7002/65 RIATA ST LEAD, (B)(6), (B)(4), IMPLANT DATE: 2008-(B)(6), PHYSICIAN: DR. (B)(6), EXPLANT DATE: 2010-(B)(6), HOSPITAL: (B)(6), EVENT DATE: 2010-(B)(6), EVENT DESCRIPTION/REASON FOR RETURN: IT WAS REPORTED TO ST. JUDE MEDICAL THAT THE PATIENT DIED DUE TO UNDELIVERED THERAPY. INVESTIGATION/TESTING: THE DEVICE AND THE LEAD WERE RETURNED FOR ANALYSIS. THE LEAD WAS RETURNED IN TWO PARTS, CUT AT 62 CM FROM THE CONNECTOR END. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND SEVERAL ARCS AND BURN MARKS ON THE ICD CAN. BODY FLUID STAINS WERE ALSO OBSERVED IN THE HEADER. THE DEVICE WAS INTERROGATED AND FOUND TO BE IN TACHY ONE ZONE CONFIGURATION, VVI PACING MODE WITH A PROGRAMMER MESSAGE STATING "POSSIBLE OUTPUT CIRCUIT DAMAGE DETECTED". THE BATTERY VOLTAGE WAS FOUND TO BE 2.72V. THE LAST MAXIMUM VOLTAGE CHARGE OCCURRED (B)(6) 2010, WHILE THE DEVICE WAS IMPLANTED. THE CHARGE TIME WAS 7.9 SECONDS. A REVIEW OF THE DIAGNOSTIC SUMMARY FOUND THAT THERE HAD BEEN A TOTAL OF 65 ABORTED CHARGES DUE TO POSSIBLE OUTPUT CIRCUIT DAMAGE. THE FIRST CHARGE WAS ABORTED ON (B)(6) 2010. THE DEVICE WAS CONNECTED TO A CARDIAC SIMULATOR AND IT WAS FOUND THAT THE DEVICE SENSED THE CARDIAC SIGNALS PROPERLY. NO NOISE WAS OBSERVED ON THE REAL-TIME EGM. A SOSD -SHORTED OUTPUT STAGE DETECTION- MESSAGE WAS RECEIVED WHEN A HIGH VOLTAGE LEAD IMPEDANCE CHECK WAS PERFORMED. THIS INDICATED THAT THE HIGH VOLTAGE OUTPUT TRANSISTORS WERE SHORTED. AN AUTOMATED TESTING OF THE LOW VOLTAGE FUNCTIONS WAS PERFORMED AND THE DEVICE MET ALL SPECIFICATIONS. FURTHER ANALYSIS OF THE ARC MARK ON THE CAN, WITH AN ENERGY DISPERSIVE X-RAY SPECTROGRAPHY -EDX- FOUND PRESENCE OF LEAD MATERIAL. VISUAL INSPECTION OF THE RETURNED LEAD FOUND AN INSULATION ABRASION AT 17.3-18.6 CM FROM THE CONNECTOR END. ONE OF THE TWO RV CABLES WAS FRACTURED AND MELTED AT THE TIP, 18.2 CM FROM THE CONNECTOR END. ELECTRICAL MEASUREMENTS FOUND NORMAL LEAD CHARACTERISTICS ON BOTH PARTS OF THE LEAD. CONCLUSION: THE REASON OF THE RETURN WAS CONFIRMED. SEVERAL ARC MARKS WERE FOUND ON THE ICD CAN. IT IS BELIEVED THAT DURING A HIGH VOLTAGE THERAPY DELIVERY, THE LEAD ARCED TO THE CAN, WHICH DAMAGED THE HIGH VOLTAGE OUTPUT CIRCUITRY OF THE DEVICE. ANALYSIS OF THE RETURNED LEAD CONFIRMED, THERE WAS AN INSULATION ABRASION, AT 17.3 - 18.6 CM FROM THE CONNECTOR END. THE LOCATION OF THE ABRASION IS CONSISTENT WITH THAT OF FRICTION TO THE CAN. FURTHER EXAMINATION REVEALED THAT ONE OF THE TWO RV CABLES IS FRACTURED AND MELTED AT THE ABRASION SITE, 18.2 CM FROM THE CONNECTOR END. THE CONDITION IS CONSISTENT WITH THAT OF ARCING TO THE CAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE RIATA ICD LEAD ST. JUDE RIATA ICD LWS ST. JUDE MEDICAL V--196 EPIC + VR 50001690-001

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death