BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170862 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10300
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 25, 2004
    Report Date
    July 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THAT TIME AN INVASIVE EXAMINATION OF THE DEVICE SYSTEM WAS UNREMARKABLE FOR ANY ABNORMALITIES. THE RATE/SENSE IMPEDANCE HAD NORMALIZED. HIGH-ENERGY TESTING CONFIRMED APPROPRIATE DEVICE DETECTION AND THERAPY-DELIVERY, AS WELL AS LEAD IMPEDANCE MEASUREMENTS. NO CHANGES TO THE SYSTEM WERE MADE. ADDITIONAL INFORMATION RECEIVED INDICATES THIS LEAD WAS ATTEMPTED TO BE EXTRACTED DURING A DEVICE CHANGEOUT PROCEDURE. HOWEVER, THE EXTRACTION FAILED AND A PORTION OF THE LEAD PLANNED TO BE RETURNED. AGAIN, IT WAS NOTED THAT THE PACING IMPEDANCES WERE OUT OF RANGE. AT THIS TIME THE LEAD PORTION HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED LEAD SEGMENT WAS PERFORMED. THE LEAD RETURNED WAS SEVERED 131 MM FROM THE TERMINAL PIN AND ONLY THE PROXIMAL SECTION WAS RETURNED. SET SCREW MARKS WERE NOTED ON ALL TERMINALS, 2 ON EACH. DRIED BLOOD/BODY FLUID WAS ALSO NOTED IN THE RS- LUMEN. ELECTRICALLY, THE LEAD SEGMENT RETURNED WAS CONTINUOUS. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION WITH THE LEAD SEGMENT RETURNED.

    Description of Event or Problem · 1

    GUIDANT RECEIVED INFORMATION APPROXIMATELY (B)(6) AGO THAT THIS IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD MEASURED HIGH PACING THRESHOLDS AND AN OUT-OF-RANGE PACING IMPEDANCE OF >3000 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R 0157| 1860| 0062| 1600