BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1851504 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14069
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE'S PROGRAMMED PARAMETER SETTINGS AND THERAPY HISTORY WERE USED TO ESTIMATE EXPECTED BATTERY USE TO DATE, THEN COMPARED TO ACTUAL USE. OUR INITIAL ANALYSIS SHOWED THIS DEVICE DID NOT MEET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES. ADDITIONAL ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    EXTERNAL VISUAL INSPECTION NOTED BODY FLUID CONTAMINATION IN THE LEAD BARRELS. THERE WERE HOLES IN THE DEFIBRILLATION POSITIVE, RIGHT ATRIAL NEGATIVE, RIGHT ATRIAL POSITIVE AND RIGHT VENTRICULAR NEGATIVE SEALPLUGS. THE OTHER TWO SEALPLUGS WERE INTACT. ALL SETSCREWS OPERATED NORMALLY. A REVIEW OF THE STORED ELECTROGRAMS NOTED MECHANICAL NOISE ON THE RV CHANNEL THAT IS CONSISTENT WITH LEAD DAMAGE. ALL RECORDED VENTRICULAR THRESHOLD MEASUREMENTS FROM THE DEVICE'S TIME IN SERVICE WERE HIGH. THE VENTRICULAR THRESHOLD AT IMPLANT WAS NORMAL.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. RETURN OF THE DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL ANALYSIS AND TESTING REVEALED THE DEVICE DECLARED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. THE EOL (END OF LIFE) INDICATOR WAS NOT DECLARED WHILE THE DEVICE WAS IN SERVICE. TESTING CONFIRMED ALL DEVICE THERAPIES WERE AVAILABLE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS DEVICE WAS EXPLANTED DUE TO ITS ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS, WHICH WAS SUSPECTED TO BE DUE TO AN EXTENDED CHARGE TIME EXCEEDING SPECIFICATION. THIS DEVICE IS INCLUDED IN THE NOVEMBER 27, 2007 MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION. THE REPRESENTATIVE REPORTED THE PATIENT HAD BEEN LOST TO CLINICAL FOLLOW-UP FOR APPROXIMATELY TWO YEARS. IT ALSO WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOSS OF CAPTURE, AND INCREASED PACING THRESHOLDS. IT SUBSEQUENTLY WAS REPORTED THAT THE LEAD HAD EXPERIENCED A FRACTURE DUE TO CLAVICULAR CRUSH. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention T167| 4087| 0185