BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3210463 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07353
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    February 22, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. THE DEVICE WAS EXPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310438 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 1857| 1749| 1715| 4320| 6931| T177| 0010| 1600| 6024| 0041