BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913208 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17136
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    September 10, 2012
    Report Date
    March 28, 2013
    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

    THE PROGRAMMED CONFIGURATION WAS REPROGRAMMED TO RV COIL TO CAN AND ACCEPTABLE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE DEVICE AND LEAD AND CONSIDER DEFIBRILLATION THRESHOLD (DFT) TESTING IN THE FUTURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS EXPLANTED AND REPLACED TWO MONTHS LATER. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE LOCAL FIELD REPRESENTATIVE THAT AFTER THE SHOCKING CONFIGURATION HAD BEEN REPROGRAMMED, DEFIBRILLATION THRESHOLD (DFT) TESTING WAS COMPLETED SUCCESSFULLY AND REVEALED STABLE MEASUREMENTS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD NOTED BOTH THE INTERNAL AND THE EXTERNAL INSULATION WAS ABRADED THROUGH TO THE CONDUCTOR COIL. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION. LABORATORY ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS THAT WERE ABLE TO BE REPRODUCED WITH POCKET MANIPULATION. IT WAS NOTED THAT THE SHOCK VECTOR HAD BEEN PROGRAMMED TRIAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY OF A LEAD INSULATION ISSUE VERSUS A CONNECTION ISSUE AND DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20025 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R 4136| T175| E102| 0184