BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3043586 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02716
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 20, 2008
    Report Date
    February 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE 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, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILDUP 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT FELL OFF A LADDER AND SPENT APPROXIMATELY A MONTH AND A HALF IN THE HOSPITAL RECOVERING. DURING THE INTERROGATION IT WAS NOTED THAT FOUR MONTHS EARLIER THERE WAS A SIGNIFICANT DECREASE IN SHOCKING AND PACING IMPEDANCE. HOWEVER THE IMPEDANCE RECOVERED SHORTLY AFTERWARD. NO OUT OF RANGE SHOCKING OR PACING IMPEDANCE MEASUREMENTS WERE OBSERVED AND NO NOISE WAS NOTED. BUT THEN IT RECOVERED. NO FURTHER ACTION WAS TAKEN AT THAT TIME. THE DEVICE WAS EXPLANTED OVER FOUR YEARS LATER FOR REPORTED NORMAL BATTERY DEPLETION AND RETURNED FOR STANDARD ANALYSIS TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146597 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 0185| T175