BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 3210392 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07388
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN PLANNED TO REPLACE THE DEVICE WITH ANOTHER MANUFACTURER'S DEVICE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO THE HOSPITAL AFTER RECEIVING SHOCK THERAPY. ADDITIONALLY, THE PATIENT REPORTED EXPERIENCING DIZZINESS. UPON INTERROGATION OF THE DEVICE, A CHARGE TIME OUT FAULT MESSAGE WAS OBSERVED. REVIEW OF DEVICE MEMORY REVEALED THAT FOUR DELIVERED SHOCKS AND 183 DIVERTED THERAPIES. THE DEVICE'S MONITORING VOLTAGE WAS 2.34 AND THE CURRENT CHARGE TIME WAS 15 SECONDS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED REPLACING THE DEVICE AND DISCUSSED STORAGE MODE WHEN THE DEVICE REACHES A BATTERY VOLTAGE OF 2.20. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310598 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR T180| 4470| 1851| 0144