BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 2041809 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01543
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT WAS LOST TO FOLLOW UP. THE LAST INTERROGATION WAS LIKELY TWO YEARS AGO BASED ON THE LATEST THRESHOLD TEST RESULTS SHOWN ON THE PROGRAMMER. THE FIELD REPRESENTATIVE NOTED A FAULT CODE WARNING MESSAGE THAT INDICATED A DEVICE CHARGE TIME GREATER THAN 45 SECONDS OCCURRED WHICH LIKELY TRIGGERED END OF LIFE (EOL) EIGHT MONTHS AGO. TWO MONTHS AGO THE DEVICE REVERTED TO STORAGE MODE. NOW THE BATTERY VOLTAGE MEASURED 2.18 VOLTS WITH A CHARGE TIME OF 33.5 SECONDS. THE LAST DELIVERED SHOCK WAS ON THE DAY THE DEVICE WAS IMPLANT. TECHNICAL SERVICES (TS) DISCUSS THAT THE DEVICE CURRENTLY HAS NO THERAPY AVAILABLE IN STORAGE MODE SO THE PATIENT WAS NOT PROTECTED AND RECOMMEND REPLACING THE DEVICE AS SOON AS POSSIBLE. THE PATIENT IS NOT PACEMAKER DEPENDANT. THIS DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. DURING THE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT OF RANGE IMPEDANCE MEASUREMENTS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND A LEAD FRACTURE WAS SUSPECTED. THE RV AND RA LEAD'S WERE SURGICALLY ABANDONED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL 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 T165

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R 0180| T165| E110| 4086| 0157