BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2162515 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07079
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    December 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING DEVICE EXPLANT AND COMPLETION OF LAB ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION STATES THIS DEVICE HAS SINCE BEEN REPLACED; HOWEVER, NO INFORMATION COMMUNICATED ON THE STATUS OF THE RETURN OR THE REPLACEMENT PRODUCT. IF NEW DETAILS ARE RECEIVED, ANOTHER REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RETURN OF PRODUCT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY ANALYZED. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI), WITH INTERROGATION CONFIRMING ERI STATUS PROMPTED DUE TO INCREASED CHARGE TIMES. THE FIELD REPRESENTATIVE QUESTIONED WARRANTY AND COMMUNICATED THE DEVICE WOULD BE SCHEDULED FOR EXPLANT IN THE UPCOMING MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 61 YR Hospitalization| R T175| 0185