BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIENT

    MDR report key: 1952649 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23594
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    October 14, 2010
    Report Date
    February 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS 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.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S SYSTEM HAD EXHIBITED INCREASED PACING IMPEDANCES WHICH ARE NOW NOTED TO BE OUT OF RANGE WITH A VALUE OF GREATER THAN 2,000 OHMS. IT WAS REPORTED THAT THE PHYSICIAN IS CONSIDERING REPLACING THE LEAD AS THE PATIENT HAS A SUBCALVIAN STENT VERY CLOSE TO THE LEAD. AT THIS TIME, THE CAUSE OF THE HIGH IMPEDANCES IS UNKNOWN. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS ICD WAS EXPLANTED DURING THE RV LEAD REVISION PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS SYSTEM'S RV LEAD WAS BEING EXTRACTED FOR PROBABLE LEAD FRACTURE; HOWEVER, HAS NOT BEEN CONFIRMED AT THIS TIME. AN ATTEMPTED EXPLANT PROCEDURE WAS PERFORMED; HOWEVER, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY REMOVE THE LEAD. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR EXTRACTION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 4479| E030| 0184