BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3041133 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01688
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED NOISE ON THE RATE\SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WHICH RESULTED IN OVERSENSING AND PACING INHIBITION GREATER THAN TWO SECONDS. THE PACING INHIBITION WAS NOT A FACTOR DUE TO THE INTRINSIC RATE OF 60 BEATS PER MINUTE (BPM) AND THE DEVICE PROGRAMMING OF DUAL CHAMBER SENSING AND PACING AND RESPONSE. A LEAD REVISION PROCEDURE WAS PERFORMED AND DUE TO THE LONGEVITY OF THE DEVICE, THE PHYSICIAN ELECTED TO REPLACE THE DEVICE AT THE TIME OF THE LEAD REVISION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143077 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R T165| 1488K| 0125| 1762| 1861