BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC DR

    MDR report key: 2243115 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06634
    Event Type
    Death
    Date Received
    September 11, 2011
    Date of Event
    August 26, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS INDICATED THE OUTPUT CIRCUITRY OF THE DEVICE WAS DAMAGED. IT IS BELIEVED THAT THE LEAD ARCED TO THE ICD CAN, CAUSING A LOW IMPEDANCE PATH THAT RESULTED IN THE DAMAGE. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED SYSTEM. ALL LOW VOLTAGE FUNCTIONS WERE NORMAL.

    Additional Manufacturer Narrative · 1

    CORRECTION OF ANALYSIS - THE LEAD ARCED BETWEEN RV COILS NEAR THE DISTAL TIP; THIS RESULTED IN HV OUTPUT CIRCUITRY DAMAGE IN THE ICD DEVICE.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED EVALUATION OF DEVICE DIAGNOSTICS BY TECHNICAL SERVICES NOTES OUTPUT CIRCUIT DAMAGE WAS DETECTED ON (B)(6) 2011 AT 1:16AM. ASIDE FROM THE DIAGNOSTICS, NO EGM INFORMATION IS AVAILABLE FROM THAT EPISODE, LIKELY DUE TO DEVICE MEMORY CONSTRAINTS. THE FIRST EGM STORED BY THE DEVICE ON (B)(6) 2011, 1:52AM NOTES PATIENT IN VF. THE DEVICE DETECTED VF, BUT ALL 6 HV SHOCKS WERE ABORTED DUE TO (B)(6). THERE APPEARS TO BE EXTERNAL DEFIB NOTED, BUT THE EPISODE ENDS WITH PATIENT STILL IN VF.

    Description of Event or Problem · 1

    AMBULANCE PERSONNEL REPORTED FINDING THE PATIENT IN VF UPON ARRIVAL. THE PATIENT COULD NOT BE RESUSCITATED. DEVICE INTERROGATION AT THE CORONER'S OFFICE REVEALED THAT THE PATIENT HAD A VT THAT WAS FIRST TREATED WITH ATP WHICH SPEED UP THE RHYTHM TO VF. THE DEVICE DELIVERED 2 HV SHOCKS THAT DID NOT TERMINATE THE VF. FOLLOWING THE SECOND SHOCK, THE DEVICE REPORTED LOW HVLI AND POSSIBLE OUTPUT CIRCUIT DAMAGE, WHICH PREVENTED FURTHER THERAPY DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIC DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-233 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death 1580/65, (B)(4), 1688T/52, (B)(4)