BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5953170 · Received September 15, 2016

    Report

    Report Number
    3007566237-2016-03274
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    June 13, 2016
    Report Date
    September 15, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION; CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VAN DER WILT, A.A., VAN WUNNIK, B.P., STURKENBOOM, R., HAN-GEURTS, I.J., MELENHORST, J., BENNINGA, M.A., BAETEN, C.G.M.I., BREUKINK, S.O. SACRAL NEUROMODULATION IN CHILDREN AND ADOLESCENTS WITH CHRONIC CONSTIPATION REFRACTORY TO CONSERVATIVE TREATMENT. INT. J. COLORECTAL DIS. 2016. 31(8):1459-1466. DOI 10.1007/S00384-016-2604-8. SUMMARY: THE AIM OF THIS STUDY WAS TO EVALUATE WHETHER THE SHORT-TERM EFFECTS OF SACRAL NEUROMODULATION (SNM) IN CHILDREN AND ADOLESCENTS WITH CONSTIPATION ARE SUSTAINED OVER PROLONGED PERIOD OF TIME. REPORTED EVENTS: PATIENT 11: A (B)(6) FEMALE PATIENT WITH SACRAL NEUROMODULATION (SNM) FOR REFRACTORY CONSTIPATION HAD THEIR ELECTRODE REMOVED WITHIN A YEAR POST-IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605573 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention