BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE 0158/181246 IMPLANTED 05-FEB-2009

    MDR report key: 1605077 · Received February 10, 2010

    Report

    Report Number
    2124215-2009-24496
    Event Type
    Injury
    Date Received
    February 10, 2010
    Date of Event
    October 24, 2009
    Report Date
    June 12, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD ALONG WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. AN ALERT WAS DECLARED THROUGH LATITUDE. THERE WAS A STORED EPISODE WITH NOISE ON IT. THE DAILY MEASUREMENTS INDICATE THAT THE IMPEDANCES HAVE BEEN VARYING. IT WAS REPORTED THAT THE PATIENT WAS TO BE BROUGHT INTO THE EMERGENCY ROOM FOR FURTHER EVALUATION. SUBSEQUENT INFORMATION INDICATED THAT THE RV LEAD WAS SUSPECTED TO BE FRACTURED; HOWEVER, AN X-RAY HAD NOT BEEN PERFORMED. THE PATIENT WAS TO UNDERGO A REVISION PROCEDURE IN THE NEAR FUTURE. SUBSEQUENT INFORMATION INDICATES THAT THE RV LEAD WAS SURGICALLY CAPPED AND A NEW RV LEAD WAS PLACED. WHEN THE LEAD WAS TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA) THE IMPEDANCE WAS 1008 OHMS. AT THIS TIME WE ARE UNABLE TO CONFIRM THE CAUSE FOR HIGH IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 0158/181246 IMPLANTED 05-FEB-2009 IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R