BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 897119 · Received August 10, 2007

    Report

    Report Number
    2124215-2007-99695
    Event Type
    Death
    Date Received
    August 10, 2007
    Date of Event
    July 12, 2007
    Report Date
    August 9, 2007
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. ELECTROGRAMS WERE REVIEWED. INITIALLY THERE WAS QUESTION OF NOISE; HOWEVER, DUE TO THE LACK OF A SHOCK ELECTROGRAM, IT WAS DIFFICULT TO DETERMINE IF IT WAS RELATED TO AN ARRHYTHMIA. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED POSSIBLE MISSING OR MISALIGNED MARKERS. AFTER THE PATIENT'S DEATH, A FIELD REPRESENTATIVE CALLED IN TO TS TO DISCUSS ELECTROGRAMS FURTHER, AS THEY SUSPECTED LOSS OF CAPTURE. TS REVIEWED THE ELECTROGRAM AND WAS UNABLE TO VERIFY LOSS OF CAPTURE AGAIN DUE TO THE LACK OF A SHOCK CHANNEL. THERE WAS CONFIRMATION OF VENTRICULAR ARRHYTHMIA UNDERSENSING. TS SUSPECTED THAT THE PATIENT WAS IN AN ARRHYTHMIA AND THERE WAS NOISE. THIS DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BECAME UNRESPONSIVE AT HOME. EMERGENCY MEDICAL STAFF WERE CALLED. NO ARRHYTHMIAS WERE DETECTED AT THE TIME OF THE ARREST OR DURING RESCUE BY EMERGENCY STAFF; HOWEVER, THE PATIENT DID REQUIRE EXTERNAL CARDIOVERSION. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) TRANSVENOUS LEAD WAS EXHIBITING NOISE AND VARYING PACING IMPEDANCE MEASUREMENTS. IT WAS REPORTED THAT THE PATIENT HAD RECEIVED SIX SHOCKS AND HAD THIRTY-TWO EPISODES FOR WHICH ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. THE DEVICE WAS REPORTEDLY TURNED OFF AND THE PATIENT LATER PASSED AWAY DUE TO THEIR TERMINAL CONDITION. THE TIMELINE OF WHEN THE PATIENT WENT UNRESPONSIVE RELATED TO THE RECORDED EPISODES WAS UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS T165

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 6949