BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE PS+

    MDR report key: 2812303 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17161
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    November 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN HAD DIFFICULTY IMPLANTING THE LEAD AND THE PARAMETERS WERE BAD. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELLENCE PS+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMK49B

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other