BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1873855 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17561
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 2, 2010
    Report Date
    March 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY TWO AND A HALF YEARS LATER THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND RETURNED FOR LABORATORY ANALYSIS.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.THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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

    THE BOSTON SCIENTIFIC CRM SALES REPRESENTATIVE WAS NOT AWARE OF THIS SITUATION, HOWEVER STATED HE WOULD CONTACT THE PATIENT'S PHYSICIAN TO TRY AND FURTHER INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT CONTACTED OUR COMPANY STATING SHE IS NOT FEELING WELL. SHE HAS SHORTNESS OF BREATH, EXTREME FATIGUE AND WEAKNESS IN HER LEGS. SHE STATED SHE HAD A CARDIAC CATH DONE ABOUT A MONTH AGO AND THERE WERE NO PROBLEMS. HOWEVER, THE PATIENT THEN EXPLAINED HER NEW PHYSICIAN TOLD HER SOMETHING WAS WRONG WITH HER PACEMAKER. THE PATIENT STATED SHE HAS ANOTHER APPOINTMENT WITH HER PHYSICIAN WITHIN THE NEXT WEEK IN A HALF TO HAVE HER PACEMAKER ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 4086| 4456| 1298