BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042358 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01212
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION IS RECEIVE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCES ALONG WITH A DECREASE IN R-WAVE SENSING; LEAD DISLODGMENT REPORTED. THE PHYSICIAN ELECTED TO EXPLANT THE PRODUCT AND IMPLANT ANOTHER BOSTON SCIENTIFIC LEAD OF DIFFERENT MODEL TYPE. THE EXPLANTED PRODUCT IS NOT INTENDED TO BE RETURNED FOR A POST MARKET ASSESSMENT. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention