BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3905365 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11607
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    October 9, 2012
    Report Date
    May 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INDICATED THE DEVICE WOULD NOT BE RETURNED. 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 ROUTINE FOLLOW-UP APPOINTMENT HIGH THRESHOLD MEASUREMENTS WERE NOTED. ADDITIONALLY, REVIEW OF THE DAILY MEASUREMENTS INDICATED PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS ON TWO DATES. AS THE PACING IMPEDANCE MEASUREMENTS HAD RETURNED TO A REASONABLE LEVEL, THE LEAD REMAINS IMPLANTED AND THE PATIENT WILL BE FOLLOWED APPROPRIATELY. INFORMATION WAS LATER RECEIVED THAT THE IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS PERSISTED. THE THRESHOLD MEASUREMENTS CONTINUED TO BE ELEVATED AS WELL. AS THE DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI), IT WAS INDICATED THE LEAD WOULD BE REVISED WHEN THE DEVICE WAS REPLACED. INFORMATION WAS SUBSEQUENTLY RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE CONNECTION NOTED NO ISSUE AND THE X-RAY REVEALED NO LEAD DAMAGE. THE PHYSICIAN ELECTED TO KEEP THE RV LEAD IMPLANTED. THE DEVICE WAS EXPLANTED. ALL MEASUREMENTS WERE APPROPRIATE WITH THE NEW DEVICE AND EXISTING RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382966 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 T175| 0175