BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3082655 · Received April 29, 2013

    Report

    Report Number
    2124215-2013-07023
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REMOTE HOME MONITORING TRANSMISSION FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED N/R VALUES FOR THE LAST TRANSMITTED DATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBLE CAUSES FOR THIS CLINICAL OBSERVATION. IT WAS ALSO REPORTED THAT THE MONITORING VOLTAGE OF THE DEVICE WAS 2.68 VOLTS WITH A CHARGE TIME OF 21 SECONDS. TS STATED THAT THE CHARGE TIME WAS ABOVE EXTENDED LIMIT FOR THE REPORTED MONITORING VOLTAGE. THE HEALTH CARE PROVIDER WAS GOING TO HAVE THE PATIENT PERFORM ANOTHER REMOTE INTERROGATION THE FOLLOWING DAY. ADDITIONAL INFORMATION FROM THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE INDICATED THAT THE PATIENT HAD RELOCATED TO ARIZONA AND WOULD LIKELY UNDERGO A DEVICE CHANGE OUT THERE. AVAILABLE INFORMATION INDICATES THE DEVICE REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185096 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR T177| 0158