BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2172923 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11422
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD FALLEN AND BROKEN SOME RIBS. FOLLOWING THE FALL, THIS RIGHT VENTRICULAR (RV) LEAD HAD BEEN EXHIBITING PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS WITH NOISE AND SOME OVERSENSING DUE TO A FRACTURE. THEREFORE, A LEAD REVISION WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 75 YR E102| 0158| T135