BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1951572 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23560
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    June 22, 2005
    Report Date
    December 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-08 TO Z-0053-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, ERI WAS REACHED EARLIER THAN EXPECTED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED. THE REPORTED CLINICAL OBSERVATION WAS NOT ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS CONCERNED THAT THERE WAS A PROBLEM WITH HIS DEVICE. SUBSEQUENT INFORMATION INDICATED THAT HIGH, OUT OF RANGE RIGHT VENTRICULAR (RV) PACING IMPEDANCES WERE OBSERVED. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED. THE LEAD WAS SENT BACK TO BSC FOR ANALYSIS. AT THAT TIME, THE LEAD WAS TESTED AND CONFIRMED TO HAVE MET ALL SPECIFICATION, THEREFORE, WE CAN NOT RULE OUT A CONNECTION ISSUE AS THE SOURCE OF THE OUT OF RANGE MEASUREMENTS. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE HAS BEEN RETURNED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    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 72 YR 0185| T135