BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3905686 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11148
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 26, 2013
    Report Date
    July 1, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A DEVICE UPGRADE PROCEDURE WILL TAKE PLACE IN THE FUTURE AFTER THE PHYSICIAN MANAGES THE PATIENT'S HEART FAILURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO THE HOSPITAL WITH HEART FAILURE SYMPTOMS. INTERROGATION OF THE DEVICE WITH A PROGRAMMER REVEALED A TACHYCARDIA MODE CHANGED DUE TO BATTERY STATUS AND A CHARGE TIME OUT FAULT MESSAGE. IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP SINCE IMPLANT. REVIEW OF STORED DEVICE MEMORY REVEALED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) WAS REACHED 14 MONTHS AGO AND END OF LIFE (EOL) WAS REACHED THREE MONTHS LATER. THE DEVICE WAS NOW NOTED TO BE IN STORAGE MODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED NO THERAPY AVAILABLE IN STORAGE MODE AND RECOMMENDED DEVICE REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AVAILABLE INFORMATION SUGGESTS THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384049 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R T165| 4470| 0185