BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953113 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00895
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCT: 4076 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLD. THE RA LEAD WAS REPOSITIONED AND REMAINS 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
    57238 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER