BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041734 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-03168
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. 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 VENTRICULAR LEAD WAS EXHIBITING ELEVATED THRESHOLDS DUE TO A SUSPECTED MICRODISLODGEMENT.

    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 75 YR E110| 4480| 0185