BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050098 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05159
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THIS LEAD DISPLAYED NOISE. FLUOROSCOPY WAS PERFORMED AND FOUND THAT THE LEAD HAD MOVED. A REVISION PROCEDURE WAS PERFORMED AND FOUND THAT THE LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED SUCCESSFULLY AND REMAINS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150182 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R