BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3213207 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09451
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 6, 2013
    Report Date
    March 11, 2015
    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

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THIS DEVICE WAS EXPLANTED TWO WEEKS AFTER THE DEVICE DECLARED ERI. NO BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE, AND THE EXPLANTED DEVICE WAS NOT RECEIVED IN THE BOSTON SCIENTIFIC LABORATORY. A FIELD REPRESENTATIVE INQUIRED AT THE FACILITY AND LEARNED OF THE EXPLANT PROCEDURE AND CONFIRMED THAT THE DEVICE WAS BELIEVED TO HAVE BEEN SHIPPED BACK TO BOSTON SCIENTIFIC. AS OF TODAY, THE LOCATION OF THE DEVICE IS UNKNOWN. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY TWENTY-ONE MONTHS POST-EXPLANT. UPON RECEIPT, 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.

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THIS DEVICE REMAINS IN SERVICE PENDING THE REPLACEMENT PROCEDURE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A MONITORING VOLTAGE OF 2.69 VOLTS, BUT THE CHARGE TIME WAS 24.1 SECONDS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED EXTENDED CHARGE TIMES AT MIDDLE OF LIFE, AND ASKED THE CLINICIAN TO PERFORM A MANUAL CAPACITOR REFORMATION. ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS WAS THEN DECLARED. THE DEVICE WAS SCHEDULED FOR REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311972 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

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