BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140490 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17351
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DETAILED ANALYSIS IS BEING PERFORMED ON THIS LEAD. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S (RV) LEAD HAD EXHIBITED INCREASED THRESHOLDS AND INTERMITTENT CAPTURE. THE LEAD WAS REPOSITIONED. AFTER THE REPOSITIONING THERE WERE EPISODES OF NON SUSTAINED OVERSENSING THAT LEAD TO PERIODS OF PACING INHIBITION AND NOISE. THE DEVICE PROGRAMMING WAS CHANGED IN AN EFFORT TO ALLEVIATE. LATER, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO A SYNCOPAL EVENT. UPON INTERROGATION OF THE DEVICE IT WAS NOTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE LEAD WAS THEN EXPLANTED AND REPLACED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618823 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 0293