BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2040666 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00651
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 17, 2010
    Report Date
    March 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. LABORATORY TECHNICIANS UTILIZED AN ENGINEERING LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL BELOW AN ACCEPTABLE RANGE. THE ROOT CAUSE OF THE RAPID BATTERY DEPLETION COULD NOT BE DETERMINED DESPITE EXTENSIVE DEVICE TESTING. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE CLINICALLY OBSERVED NOISE ISSUE AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THERE WAS NOISE OBSERVED ON THE RIGHT VENTRICULAR (RV) CHANNEL; HOWEVER, NO NOISE OR INAPPROPRIATE THERAPY WERE NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION DURING A LEAD EXTRACTION PROCEDURE, WHERE A LEAD FRACTURE WAS SUSPECTED. THE DEVICE WAS LATER RETURNED AND ROUTINE INITIAL DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR 0158| T180| 4473| 1853