BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860503 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14931
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A NORMAL FOLLOW UP, THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD PRESENTED WITH A DECREASE IN AMPLITUDE AND PACING IMPEDANCES AND AN INCREASE IN PACING THRESHOLDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS SCHEDULED TO BE SEE AGAIN AND HAVE AN CHEST X-RAY TAKEN. AT THE NEXT FOLLOW UP, IT WAS NOTED THAT THE PACING IMPEDANCES HAD CONTINUED TO INCREASE. A CHEST X-RAY WAS PERFORMED AND IT APPEARED THAT THIS LEAD HAD PULLED BACK FROM THE HEART WALL. A REVISION WAS PERFORMED AND THIS DEFIBRILLATION LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED IN RELATION TO THE PROCEDURE.

    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 70 YR Required Intervention 0185| 4087| E110| T125