BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3040661 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01100
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 23, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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, THE DEVICE WAS FOUND TO EXHIBIT NO TELEMETRY AND A MEMORY DOWNLOAD WAS UNABLE TO BE PERFORMED. VISUAL INSPECTION OF THE DEVICE FOUND THE CASE TO BE SWELLED OVER THE BATTERY LOCATION. THE BATTERY WAS REPLACED WITH AN EXTERNAL POWER SUPPLY AND THE DEVICE WAS FUNCTIONING WITHIN NORMAL SPECIFICATIONS. TESTING CONFIRMED THAT THE LACK OF TELEMETRY WAS THE RESULT OF LEAVING THE DEVICE IMPLANTED LONGER THAN THE NORMAL LIFE EXPECTANCY OF THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE WAS LOST TO FOLLOW UP FOR APPROXIMATELY THREE YEARS. THE PATIENT CURRENTLY RESIDED IN A NURSING HOME AND SUFFERS FROM DEMENTIA. THE PATIENT WAS PRESENTED FOR AN UNSPECIFIED REASON, HOWEVER, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS UNABLE TO BE INTERROGATED SUCCESSFULLY. THE PATIENT'S PHYSICIAN SPOKE WITH TECHNICAL SERVICES, WHO OFFERED TROUBLESHOOTING RECOMMENDATIONS. THE LOCAL AREA SALES REPRESENTATIVE ATTEMPTED TO INTERROGATE THE DEVICE, HOWEVER, NO RESPONSE WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT COMPLICATION. NO DEVICE ALLEGATIONS WERE PRESENTED. THE DEVICE WAS TO BE RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143847 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R T165| 4470| 0185