BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 3051497 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04871
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UNKNOWN ST JUDE IMPLANTABLE PACEMAKER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR COMPETITOR DEVICE NEEDS REPLACING AND WAS TOLD THAT ONE OF THEIR LEADS IS BAD AND NEEDS REPLACING. FOLLOW-UP IS IN PROGRESS AND IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE ADDED TO THE EVENT. THE RIGHT VENTRICULAR LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148706 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-52

    Patients

    Seq Age Sex Outcome Treatment
    1 5068 IMPLANTABLE PACING LEAD