BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1190318 · Received October 6, 2008

    Report

    Report Number
    2182207-2008-06346
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 7, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: DUDDING TC, MENG LE, FAIZ O, ET AL. ECONOMIC EVALUATION OF SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE. BR J SURG. 2008;95(9):1155-1163. SACRAL NERVE STIMULATION (SNS) IS AN ESTABLISHED TREATMENT FOR FECAL INCONTINENCE IN PATIENTS WHO HAVE FAILED CONSERVATIVE MANAGEMENT. THIS STUDY ESTABLISHED THE COST- EFFECTIVENESS OF TREATING PATIENTS WITH SNS COMPARED WITH NON-SURGICAL TREATMENT. A COHORT ANALYSIS WAS PERFORMED BASED ON PROSPECTIVELY COLLECTED DATA ON PATIENTS WHO HAD UNDERGONE SNS AT A SINGLE INSTITUTION BETWEEN 1996 AND 2006. DATA WAS AVAILABLE ON A TOTAL PATIENTS. SYMPTOMS OF FECAL INCONTINENCE HAD BEEN PRESENT FOR A MEDIAN OF 7 (RANGE 2?24) YEARS BEFORE SURGERY AND ALL PATIENTS HAD FAILED TO BENEFIT FROM PREVIOUS CONSERVATIVE TREATMENTS. THIS STUDY HAS DEMONSTRATED THAT SNS IS A COST- EFFECTIVE TREATMENT. REPORTABLE EVENT: TWO PATIENTS HAD THE NEUROSTIMULATOR REPLACED DUE TO DEVICE COMPONENT FAILURE. SEE MFG REPORT 2182207200806343.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL UNK N=1| PROGRAMMER MODEL UNK N=1