BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3153008 · Received June 8, 2013

    Report

    Report Number
    2182208-2013-01379
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4): ADD01 IMPLANTABLE PULSE GENERATOR (IPG) 2008-(B)(6); 5076 IMPLANTABLE PACING LEAD 2008-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. A REPOSITION ATTEMPT WAS NOT SUCCESSFUL AND THE RA LEAD WAS REMOVED AND WAS NOT REPLACED. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254469 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC INC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R