BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871871 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17625
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE REPORTED THAT DURING THE INVASIVE PROCEDURE, A LOOSE SETSCREW WAS CONFIRMED. THE CONNECTION WAS TIGHTENED AND THIS RESOLVED THE OUT OF RANGE IMPEDANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD AND DEVICE REMAIN IN SERVICE WITHOUT FURTHER COMPLICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD AND ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED RIGHT VENTRICULAR PACING IMPEDANCE MEASUREMENTS OF >2000 OHMS. PACING THRESHOLDS HAD INCREASED. NOISE WAS OBSERVED ON THE RV AND SHOCK CHANNELS. A CHEST X-RAY SHOWED NO LEAD MOVEMENT. TECHNICAL SERVICES DISCUSSED TRYING TO RECREATE THE NOISE WITH POCKET MANIPULATION. TECHNICAL SERVICES DISCUSSED A POTENTIAL CONNECTION ISSUE OR LEAD ISSUE. THE FIELD REPRESENTATIVE LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 4087| 0185| T125| E110