BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2737963 · Received September 10, 2012

    Report

    Report Number
    3004209178-2012-07949
    Event Type
    Injury
    Date Received
    September 10, 2012
    Report Date
    August 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V863548 SERIAL# IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6). PRODUCT TYPE LEAD PRODUCT ID, 3093-28 LOT# VA00CEY SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEAD REPLACEMENT DONE; HOWEVER, HER PATHOLOGY REPORT CAME BACK POSITIVE FOR AN INFECTION SO THE ENTIRE SYSTEM WAS REMOVED, INCLUDING THE NEW LEAD. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET. A CULTURE WAS DONE, BUT THE RESULTS WERE NOT PROVIDED. THE PATIENT DID NOT HAVE MENINGITIS AND PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. IT WAS NOTED THAT THE PATIENT BEFORE IMPLANTATION OF THE DEVICE HAD CANCER. PATIENT OUTCOME WAS NOT PROVIDED.

    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