BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1043053 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33582
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 17, 2008
    Report Date
    August 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT ADDITIONAL COMPLICATION. IF ANY ADDITIONAL INFORMATION RELATED TO THIS INCIDENT BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BRADYCARDIA RATES AROUND 40 BEATS/MINUTE. THE DEVICE IS PROGRAMMED TO VVIR WITH A LOWER RATE LIMIT SETTING OF 60. TECHNICAL SERVICES DISCUSSED THE POSSIBILITY OF LOSS OF CAPTURE OR OVERSENSING. IT WAS NOTED THAT THE CALLER WOULD DISCUSS A DEVICE CHECK WITH THE MD AND WOULD PAGE THE BSC REPRESENTATIVE IF NEEDED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other THE DEVICE 6481 010124 WAS USED DURING THE EVENT.| THE DEVICE 0158/166801 WAS IMPLANTED 26-OCT-2006| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 0158/166801 WAS IMPLANTED (B)(6) 2006| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 010124 WAS USED DURING THE EVENT.