BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TBD

    MDR report key: 2955348 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01447
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MPRI
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    EROSION OF THE POCKET AND "POSSIBLE" INFECTION WERE REPORTED. THE DEVICE AND LEADS WERE REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59143 TBD DXY MPRI ICF09B45

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R