BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871682 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18593
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THIS LEAD WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS. THE LEAD WAS SEVERED DURING THE EXPLANT PROCEDURE, AND BOTH SEGMENTS WERE RETURNED. A VISUAL INSPECTION OF THE LEAD SEGMENTS FOUND NO EVIDENCE OF BUCKLING, AND THE CLINICAL OBSERVATIONS WERE UNABLE TO BE CONFIRMED. ANALYSIS VERIFIED THAT BOTH LEAD SEGMENTS WERE ELECTRICALLY CONTINUOUS. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT DEVELOPED A SYSTEM INFECTION. THE PATIENT'S DEVICE AND TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AS A RESULT OF THIS OBSERVATION. THE PHYSICIAN CLAIMED THAT THE RV LEAD EXHIBITED BUCKLING BETWEEN THE PROXIMAL AND DISTAL SHOCK ELECTRODES WHEN LEAD REMOVAL WAS ATTEMPTED. THIS BUCKLING APPARENTLY MADE IT DIFFICULT TO ADVANCE A LASER SHEATH OVER THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION, AND THE LEAD EXPLANT WAS ULTIMATELY SUCCESSFUL.

    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 37 YR Life Threatening| R 0184| T177