BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5954846 · Received September 15, 2016

    Report

    Report Number
    3007566237-2016-03282
    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

    AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. EVENT DATE: 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. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3058, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.

    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 FOR UNIDENTIFIED PATIENTS: 5 FEMALE PATIENTS WITH SACRAL NEUROMODULATION (SNM) FOR REFRACTORY CONSTIPATION EXPERIENCED PAIN AT THE STIMULATOR SITE, SO THE POSITION OF THE DEVICE WAS REVISED; 6 FEMALE PATIENTS WITH SACRAL NEUROMODULATION (SNM) FOR REFRACTORY CONSTIPATION UNDERWENT A LEAD REVISION DUE TO A RECURRENCE OF SYMPTOMS; 1 FEMALE PATIENT WITH SACRAL NEUROMODULATION (SNM) FOR REFRACTORY CONSTIPATION EXPERIENCED AN INFECTION OF THE ELECTRODE, SO THE ELECTRODE WAS REMOVED AND A NEW TEST WAS PERFORMED AFTER 4 WEEKS; 6 FEMALE PATIENTS WITH SACRAL NEUROMODULATION (SNM) FOR REFRACTORY CONSTIPATION REPORTEDLY "FAILED ON SNM," WHICH THE AUTHORS DEFINED AS HAVING A DEFECATION FREQUENCY OF LESS THAN THREE TIMES PER WEEK OR THE NEED FOR USE OF LAXATIVES OR BOWEL LAVAGE TO CONTROL SYMPTOMS. THESE PATIENTS UNDERWENT A TOTAL COLECTOMY AND SUBSEQUENTLY HAD THE STIMULATOR REMOVED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION (I.E. SERIAL NUMBERS) FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605274 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention