BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1040037 · Received May 7, 2008

    Report

    Report Number
    3004209178-2008-02435
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    December 25, 2006
    Report Date
    April 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S INTERSTIM DEVICE WAS REMOVED DUE TO INFECTION. THE PT EXPERIENCED REDNESS, SWELLING, AND PAIN AT THE DEVICE POCKET SITE. A CULTURE WAS TAKEN FROM THE DEVICE POCKET WHICH REVEALED GRAM POSITIVE COCCI. IV ANTIBIOTICS WERE ADMINISTERED, THE TOTAL DEVICE SYSTEM EXPLANTED, AND THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3093| EXPLANTED| EXPLANTED| EXTENSION MODEL 3095