BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1874027 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18000
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSVENOUS DEFIBRILLATION LEAD, THE TVI TOOL WAS DROPPED PRIOR TO THE LEAD IMPLANT. THE PHYSICIAN OPTED TO IMPLANT THE LEAD WITHOUT THE TVI TOOL. IT WAS QUESTIONED HOW THIS WOULD IMPACT THE LEAD. ADDITIONALLY IT WAS NOTED THE SHOCK IMPEDANCES WERE INITIALLY 41 OHMS, THEN FLUCTUATED DOWN TO LESS THAN 20 OHMS. THE PHYSICIAN HAD PARTIALLY CLOSED THE POCKET, THUS DECIDED TO REOPEN TO REINSERT THE DEFIBRILLATION PINS. THE SHOCK IMPEDANCES WERE THEN NOTED TO BE STABLE, THUS THE POCKET WAS CLOSED AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WITH NORMAL IMPEDANCES. THE DEVICE WAS CHECKED AGAIN AT THE POST-OPERATIVE CHECK AND IMPEDANCES WERE AGAIN NOTED TO BE STABLE. IT WAS QUESTIONED WHAT WOULD HAVE CAUSED THE FLUCTUATIONS AT IMPLANT. TECHNICAL SERVICES (TS) DISCUSSED THAT TYPICALLY THESE FLUCTUATIONS ARE DUE TO A NOISY ENVIRONMENT. TS WOULD HAVE RECOMMENDED TURNING OFF THE CAUTERY SYSTEM, IN ORDER TO REMOVE ANY ELECTRO MAGNETIC INTERFERENCE (EMI) SOURCES AND RUNNING THE IMPEDANCE TESTS AGAIN, THAT USUALLY THE IMPEDANCES WOULD STABILIZE AFTER DOING THIS. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE LEAD WAS LATER FOUND TO BE DISLODGED. IT WAS NOTED THAT DURING RV PACING, ATRIAL CAPTURE WAS BEING OBSERVED. THE LEAD WAS GOING TO BE REVISED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 4135| 0184| E110