BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3212985 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10261
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION IS KNOWN, THIS EVENT WILL BE UPDATED.

    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 DURING A FOLLOW UP VISIT, INTERROGATION REVEALED SEVERAL OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. CURRENT MEASUREMENTS WERE NORMAL. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND A SAVE TO DISK WILL BE PROVIDED. IT WAS THOUGHT THERE MAY BE A LEAD INTEGRITY ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. DURING THE FOLLOW UP VISIT, NO FURTHER ISSUES WERE OBSERVED. A DECISION WAS MADE TO PERFORM NORMAL FOLLOW UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312420 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1