BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3211602 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10323
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 9, 2013
    Report Date
    October 24, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT ADDITIONAL OUT OF RANGE SHOCK LEAD IMPEDANCES WERE DETECTED BY THIS PATIENT'S HOME REMOTE MONITORING SYSTEM. THE PHYSICIAN WAS CONSIDERING DIFFERENT FOLLOW-UP OPTIONS, BUT AT THIS TIME THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED THAT A HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE WAS DETECTED FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE FIELD REPRESENTATIVES CONSULTED WITH TECH SERVICES AND POTENTIAL CAUSES AND EVALUATION OPTIONS WERE DISCUSSED. THE PATIENT WAS SEEN IN CLINIC FOR EVALUATION. OVER THE LAST MONTH THE LEAD IMPEDANCES WERE 100 TO 120 OHMS AND ALL OTHER MEASUREMENTS ON THE LEAD WERE STABLE. ISOMETRICS WERE DONE AND NO NOISE WAS ELICITED. THERE WAS ONE STORED EPISODE IN THE LAST YEAR WHICH HAD NO NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, INFORMATION SUGGESTS THAT THIS SYSTEM REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS DONE DUE TO THE HIGH SHOCK LEAD IMPEDANCE MEASUREMENT. THE SHOCK IMPEDANCE WAS NORMAL. NORMAL FOLLOW-UP IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311717 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R T175| 0157