BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY

    MDR report key: 2030398 · Received March 28, 2011

    Report

    Report Number
    2124215-2011-05396
    Event Type
    Death
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AND THE DEVICE HAS NOT BEEN RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND/OR THE DEVICE IS RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S SON CONTACTED PATIENT SUPPORT AND REPORTED THAT THE PATIENT HAD EXPIRED IN (B)(6) 2011 FOLLOWING A CARDIAC ARREST. THE SON QUESTIONED WHETHER THE DEVICE FUNCTIONED APPROPRIATELY DURING THIS ADVERSE EVENT. THE SON INFORMED PATIENT SUPPORT THAT THE PATIENT'S MEDICAL HISTORY WAS REMARKABLE FOR MULTIPLE HEALTH ISSUES. THE PATIENT WAS ORIGINALLY ADMITTED FOR ABDOMINAL PAIN AND DIAGNOSTIC TESTING IDENTIFIED ARTERIES THAT WERE 50% AND 100% OCCLUDED. THE SON STATED THAT A STENT HAD BEEN INSERTED INTO THE 50% BLOCKED ARTERY, HOWEVER, DUE TO KIDNEY-RELATED ISSUES; A SPECIALIST WAS NOTIFIED TO EVALUATE THE OTHER OCCLUDED SITE. THE FAMILY MEMBER WAS NOT AWARE OF THE STENT MANUFACTURER OR THE LOCATION OF THE STENT. WHILE WAITING FOR FURTHER EVALUATION, THE PATIENT SUFFERED A CARDIAC ARREST THAT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) FOR FOUR MINUTES. THE FAMILY MEMBER REPORTED THAT DURING APPLICATION OF CPR, TWO RIBS WERE BROKEN. THE PATIENT WAS REVIVED BUT EVENTUALLY DIED OF ORGAN FAILURE. THE FAMILY MEMBER WAS UNAWARE IF THE DEVICE WOULD BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS BUT STATED THAT THE DEVICE WAS EXPLANTED PRIOR TO CREMATION. THE LOCAL REPRESENTATIVE WAS CONTACTED AND BOSTON SCIENTIFIC WAS NOTIFIED THAT THE PATIENT'S LAST IN-CLINIC FOLLOW-UP OCCURRED IN (B)(6) 2010. ALL DIAGNOSTIC MEASUREMENTS WERE WITHIN NORMAL RANGE AT THAT TIME. NO ANOMALIES WERE IDENTIFIED. THE LOCAL REPRESENTATIVE WAS NOT CONTACTED BY THE FUNERAL HOME FOLLOWING THIS PATIENT'S DEATH TO DEACTIVATE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death T135| 0157