BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2061019 · Received April 18, 2011

    Report

    Report Number
    2124215-2011-06562
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    February 3, 2011
    Report Date
    November 7, 2012
    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

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS DEVICE MET ALL SPECIFICATIONS DURING TESTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPIRED OVER ONE YEAR LATER. THERE WERE NO ALLEGATIONS THAT THE PATIENT'S DEATH WAS CAUSED OR CONTRIBUTED BY THE IMPLANTED DEVICE. THE DEVICE WAS EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S WIFE STATED THAT THERE WAS A PRODUCT PERFORMANCE ISSUE WITH THE LEAD AND THE PHYSICIAN TOLD THEM THAT IT WOULD NEED TO BE REPLACED. THE PATIENT ADVOCATE ALSO NOTED THAT THE PATIENT'S PULSE RECENTLY SHOWED 42 AND 48 BPM ON TWO SEPARATE BLOOD PRESSURE MONITORS AND THE PATIENT WAS IN THE HOSPITAL FOR LOW BLOOD PRESSURE. WHILE IN THE HOSPITAL THE PATIENT WENT INTO CARDIAC ARREST AND A SHOCK WAS PERFORMED. IT WAS UNCLEAR IF THE SHOCK WAS DELIVERED BY THE DEVICE OR AN EXTERNAL MACHINE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT TO THE BOSTON SCIENTIFIC SALES REPRESENTATIVE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) STATED THAT AFTER THE PATIENT HAD A DIAGNOSTIC LEFT HEART CATHETERIZATION, A DEVICE INTERROGATION SHOWED NORMAL FUNCTION OF THE PACING AND SENSING AND NO MAJOR EVENTS OR THERAPY DELIVERY. A SECOND DEVICE INTERROGATION WAS PERFORMED AFTER THE PATIENT DEVELOP AN ISCHEMIC VASOVAGAL EPISODE WITH BRADYCARDIA RATES IN THE 40 BPM AND HYPOTENSION. THE SECOND INTERROGATION OF THE DEVICE ALSO REVEALED NORMAL FUNCTION PACING AND SENSING WITH EXCELLENT NUMBERS AND NO EPISODES OF ARRHYTHMIAS ALONG WITH NO THERAPY DELIVERED AT THAT TIME. THE SR NOTED THAT THE PATIENT WAS STABLE AND THE PATIENT'S WIFE AND NURSE WERE INFORMED OF THE INTERROGATION RESULTS AND NORMAL FUNCTION OF THE DEVICE. IT WAS NOTED THAT THE PATIENT'S DEVICE WAS PROGRAMMED VVI 40. THE SR STATED THAT NO LEAD ISSUE WAS SEEN AT THE TIME OF EITHER DEVICE INTERROGATION AND WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION FROM THE HOSPITAL.

    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 74 YR Hospitalization| L 0157| 0184| 1860| T175