BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1082497 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04390
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ROTH TJ, VANDERSTEEN DR, HOLLATZ P, INMAN BA, REINBERG YE. SACRAL NEUROMODULATION FOR THE DYSFUNCTIONAL ELIMINATION SYNDROME: A SINGLE CENTER EXPERIENCE WITH 20 CHILDREN. J UROL. 2008;180(1):306-311. RECENT ADVANCES IN NEUROMODULATION HAVE DEMONSTRATED PROMISE IN TREATING CHILDREN WITH THE DYSFUNCTIONAL ELIMINATION SYNDROME REFRACTORY TO MEDICAL MANAGEMENT. SACRAL NERVE STIMULATION WITH THE INTERSTIM IMPLANTABLE DEVICE HAS BEEN USED IN ADULTS FOR MANAGEMENT OF CHRONIC URINARY COMPLAINTS. HOWEVER, THERE ARE FEW DATA REGARDING THE USEFULNESS OF SACRAL NERVE STIMULATION IN CHILDREN. WE REPORT OUR EXPERIENCE WITH SACRAL NERVE STIMULATION FOR SEVERE DYSFUNCTIONAL ELIMINATION SYNDROME. A TOTAL OF 20 PATIENTS 8 TO 17 YEARS OLD WITH THE DYSFUNCTIONAL ELIMINATION SYNDROME REFRACTORY TO MAXIMUM MEDICAL TREATMENT UNDERWENT SACRAL NERVE STIMULATION AT OUR INSTITUTION. PATIENTS WERE FOLLOWED PROSPECTIVELY FOR A MEDIAN OF 27 MONTHS AFTER THE PROCEDURE. REPORTABLE EVENT: ONE PATIENT REQUIRED DEVICE REPOSITIONING SECONDARY TO DEVICE MIGRATION.

    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 PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=1