BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1851112 · Received September 30, 2010

    Report

    Report Number
    3007566237-2010-07475
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIAL PATIENT HAD AN INFECTION AT THE LEAD/WIRE INCISION SITE FOLLOWING IMPLANT WITH SYMPTOMS OF FEVER AND DRAINAGE. THE PATIENT WAS PLACED ON INTRAVENOUS ANTIBIOTICS PRIOR TO IMPLANT PROCEDURE AND WAS CURRENTLY ON ORAL ANTIBIOTICS. IT WAS NOTED THAT SHE HAS HAD AN IMMUNE DISORDER AND MAY HAVE LUPUS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 3889, LOT# V497301| IMPLANTED: