BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1944765 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-21334
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    September 16, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THE CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE. THE NOISE WAS OVERSENSED WHICH LEAD TO PACING INHIBITION AND A SYNCOPAL EPISODE. THE PATIENT BROKE HIS WRIST FROM THE FALL. THE PATIENT ALSO RECEIVED INAPPROPRIATE SHOCK THERAPY DUE TO THE NOISE. THE PATIENT WAS SEEN FOR FOLLOW UP. ISOMETRICS WERE PERFORMED BUT WERE NOT ABLE TO ELICIT ANY NOISE. ALL LEAD MEASUREMENTS WERE GOOD AND WITH IN RANGE. THE LOCAL FIELD REPRESENTATIVE WAS TO DISCUSS THE CASE WITH THE FOLLOWING PHYSICIAN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L 5076| 5592| KDR651| T165| 0185