BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3210912 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08344
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 26, 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

    --

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. 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. THE FIELD OBSERVATION WAS CONFIRMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMAITON WAS RECEIVED THAT THE PHYSICIAN WANTED TO WAIT TO CHANGE OUT THE DEVICE AFTER THE PREVIOUS EVALUATION. HOWEVER, RECENT FOLLOW-UP SHOWED THE DEVICE WITH A MONITORING VOLTAGE OF 2.69 VOLTS AND A CHARGE TIME OF 28.4 SECONDS. THE TS AGENT RECOMMENDED THAT THE DEVICE BE CHANGED OUT, AND THE HCP WAS GOING TO REVIEW WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND AT THIS TIME CURRENT INFORMATION SUGGESTS THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    THE ICD WAS RETURNED TO BOSTON SCIENTIFIC AND WILL UNDERGO PRODUCT ANALYSIS EVALUATION. AT THIS TIME, AVAILABLE INFORMATION SUGGESTS THAT THE PATIENT RECEIVED A COMPETITOR'S DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO EXTENDED CHARGE TIMES IN MID-LIFE. THE MONITORING VOLTAGE WAS 2.72 VOLTS AND THE CHARGE TIME WAS 23 SECONDS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE HEALTH CARE PROFESSIONAL (HCP) THAT THE MONITORING VOLTAGE WAS THERE TO SUPPORT PACING AND SENSING, BUT IF THE PATIENT NEEDED TACHY THERAPY IT WOULD TAKE AT LEAST 23 SECONDS TO CHARGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309574 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R T177| 0185