BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2419549 · Received January 18, 2012

    Report

    Report Number
    3004209178-2012-00323
    Event Type
    Injury
    Date Received
    January 18, 2012
    Report Date
    December 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3093-28, LOT #V840219, IMPLANTED: (B)(6) 2011, PROGRAMMER: MODEL 3037, SERIAL #(B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION WAS DIAGNOSED ON (B)(6) 2011. THE SYMPTOMS OF INFECTION WERE REDNESS, PAIN, AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF INFECTION WAS THE DEVICE POCKET. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND HAD NO GROWTH. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. NO EXPLANT WAS REPORTED TO HAVE OCCURRED. IT WAS NOTED THAT THE INFECTION HAD RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE NEEDED TO BE REMOVED DUE TO INFECTION. THE EXPLANT WAS SCHEDULED FOR (B)(6) 2011. THE REPORTER NOTED THE DEVICE HAD BEEN WORKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention