BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1871640 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17765
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 3, 2010
    Report Date
    April 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT NOISE WAS PRESENT ON THIS WHICH LIKELY RESULTED IN THE UNNECESSARY SHOCKS. IN ADDITION, A LEAD FRACTURE WAS REPORTED AND THE PHYSICIAN FELT THAT THE RATE/SENSE SET SCREW HAD NOT BEEN COMPLETELY DOWN. THE PATIENT WAS ADMITTED FOR A LEAD REVISION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. 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 WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS COULD NOT CONFIRM THE REPORTED FIELD ALLEGATIONS.

    Additional Manufacturer Narrative · 1

    RESOLUTION HAS BEEN REQUESTED FROM THE FIELD IN WHICH IT WAS REPORTED THAT THE PATIENT WAS FURTHER EVALUATED IN CLINIC. THE PATIENT UNDERWENT AGGRESSIVE ARM MOVEMENTS AND POCKET MANIPULATION WITHOUT ANY IMPEDANCE CHANGES OR NOISE ON THE LEADS. ALL THE IMPEDANCE READINGS WERE WITHIN RANGE BETWEEN 600-700 OHMS. THE CLINIC WOULD LIKE TO CONTINUE ROUTINE FOLLOW-UP AS THIS PATIENT IS NOT DEPENDANT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED IMPEDANCES > 2500 OHMS ON THIS DEFIBRILLATION LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention (B)(4)| (B)(4)