BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2050339 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04083
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. ANALYSIS OF THIS DEVICE CONCLUDES INVESTIGATION. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY APRIL 2007 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON 4/5/2007, DISPLAYED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) WITH A CHARGE TIME MEASUREMENT OF 19.312 SECONDS AT A MONITORING VOLTAGE MEASUREMENT OF 2.67 VOLTS IN ANALYSIS. END OF LIFE (EOL) WAS NOT DECLARED. THIS DEVICE HAD BEEN EXPLANTED FOR NORMAL BATTERY DEPLETION WITHOUT ALLEGATION OF PREMATURE BATTERY DEPLETION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 0185| 4473| T175| N119| 4543