BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2243116 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06065
    Event Type
    Death
    Date Received
    September 11, 2011
    Date of Event
    August 26, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    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 FOUND EXTERNAL ABRASIONS BETWEEN 41.7CM AND 42CM FROM THE DISTAL TIP AS A RESULT OF FRICTION TO THE ICD CAN. MULTIPLE INTERNAL ABRASIONS WERE NOTED BETWEEN 11.1CM AND 29.7CM FROM THE DISTAL TIP. BOTH RV SHOCK COILS WERE COMPROMISED BETWEEN 23.5CM AND 25CM FROM THE DISTAL TIP.

    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 SOSD. 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 SPED 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 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death (B)(4)