BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4884740 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07358
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 7, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); THE COMPLETE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS APPROXIMATELY 21.5 CENTIMETERS (CM) FROM THE TERMINAL PIN. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION CONFIRMED TRILUMEN INSULATION DAMAGE (ABRASION) AND EXPOSED CONDUCTOR COILS. THE DAMAGE WAS NOTED TO BE CONSISTENT WITH CLAVICLE/FIRST-RIB ENTRAPMENT. NO FURTHER TESTING WAS PERFORMED DUE TO THE DAMAGE TO THE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INVASIVE PROCEDURE WAS PERFORMED. A LEAD INSULATION BREACH WAS NOTED UNDER THE SUTURE SLEEVE. THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW R-WAVE MEASUREMENTS AND LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. AN X-RAY WAS ORDERED AND A REVISION PROCEDURE WAS PLANNED FOR A DATE IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428208 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R N140| 4076| 4543