BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3211634 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08741
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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 BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED A YELLOW ALERT ON THE PATIENT'S HOME MONITORING EQUIPMENT STATING THAT ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN DECLARED. THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR CONFIRMATION. TS DISCUSSED ERI INDICATIONS, AND CONFIRMED THAT THE DEVICE DECLARED ERI BASED ON EXTENDED CHARGE TIMES. THE DEVICE WAS EXPLANTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310992 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 0181| T177