BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2790770 · Received October 15, 2012

    Report

    Report Number
    6000144-2012-05510
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 16, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A HEMATOMA AFTER IMPLANTATION OF THE DEVICE AND LEADS. AT THE FOLLOW UP VISITED THE PATIENT WAS NOTED TO HAVE TENDERNESS, REDNESS, AND SEROSANGUINOUS DRAINAGE AT THE INCISION SITE. IN ADDITION THERE WAS A SMALL OPENING. THE PATIENT WAS ADMITTED FOR AN INFECTED SYSTEM. THE DEVICE AND LEADS WERE REMOVED AND REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA XT DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D314DRM

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| O| R