BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2172993 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11147
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS LATER RECEIVED THAT THE PATIENT HAD DIED OF AN UNSPECIFIED CAUSE. NO ALLEGATIONS OR EVIDENCE OF A DEVICE DEFICIENCY WERE REPORTED AT THE TIME OF DEATH. THE LOCAL FIELD REPRESENTATIVE WAS CONTACTED FOR FURTHER INFORMATION, HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. THE PATIENT CONTINUES TO BE MONITORED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CHRONIC INTENSIVE CARE UNIT (ICU) PATIENT WITH MULTIPLE ARRHYTHMIA WAS GRAVELY ILL AND WAS BEING TREATED WITH MANY INTRAVENOUS MEDICATIONS. IT WAS REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED EIGHT APPROPRIATE SHOCKS DURING AN INITIAL VENTRICULAR FIBRILLATION (VF) EPISODE, HOWEVER IT WAS QUESTIONED WHY SUBSEQUENT EPISODES WERE NOT TREATED. TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAMS, AND NOTED BEATS THAT WERE UNDERSENSED WERE PRECEDED BY LARGE SIGNALS AND FOLLOWED BY A SMALLER SIGNAL RESULTING IN UNDELIVERED THERAPY AND THE PATIENT REQUIRED EXTERNAL SHOCKS. TS ALSO NOTED A VERY FINE VF SIGNAL DURING SOME EPISODES, WHICH MAY HAVE CONTRIBUTED TO THE UNDERSENSING. TS DISCUSSED THAT THE DEVICE OPERATED ACCORDING TO PROGRAMMED PARAMETERS. THE PATIENT WAS NOTED TO BE UNCONSCIOUS. PROGRAMMING OPTIMIZATION WAS MADE TO REDUCE UNDERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| L| R T175| 6949| 0185