BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771383 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12496
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 11, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED, DURING WHICH A TUG TEST WAS PERFORMED AND THE LEAD WAS SECURE. THE LEAD WAS REMOVED AND PLACED BACK INTO THE HEADER. SUBSEQUENTLY, ALL NOISE WAS GONE. IT WAS SUSPECTED TO BE SOME SORT OF A CONNECTION ISSUE. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS SUCCESSFULLY PERFORMED AND THE POCKET WAS CLOSED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED INCREASED RIGHT VENTRICULAR (RV) IMPEDANCES OF GREATER THAN 2000 OHMS. IT WAS NOTED THAT THERE WERE ALSO MULTIPLE NON SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES RECORDED THAT WERE DUE TO NOISE. THE NOISE WAS REPRODUCIBLE WITH ISOMETRICS. IT WAS NOTED THAT THE DEVICE/LEAD CONNECTION WOULD BE CHECKED. 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 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 0158| E110| 4470| 1861