BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2173107 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10544
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 19, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    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 CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILDUP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED ONE YEAR LATER, REPORTEDLY FOR NORMAL BATTERY DEPLETION. PER THE PATIENT'S REQUEST, A NEW DEVICE WAS NOT IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A HEALTH CARE PROVIDER (HCP) THAT THIS DEVICE HAD DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS EARLY DUE TO CHARGE TIME. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THAT DEVICES CAN DECLARE ERI DUE TO EITHER CHARGE TIME OR BATTERY MONITORING VOLTAGE, AND THAT DEVICE CHARGE TIME CANNOT BE FACTORED INTO REMAINING LONGEVITY ESTIMATES. HCP INDICATED THE DEVICE WOULD RETURNED FOR ANALYSIS FOLLOWING EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 77 YR Hospitalization| L| R 0185| T135