BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6090064 · Received November 9, 2016

    Report

    Report Number
    3007566237-2016-03992
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    January 1, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS WITHIN THE "STAGED APPROACH" GROUP REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE YEAR OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED AND THE SPECIFIC DATE OF PUBLICATION WAS NOT PROVIDED (ONLY THE YEAR). CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3058, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3889, PRODUCT TYPE: LEAD. PRODUCT ID 3058, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3058, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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

    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.

    Description of Event or Problem · 1

    RICE, T.C., QUEZADA, Y., RAFFERTY, J.F., PAQUETTE, I.M. DYNAMIC ARTICLE: PERCUTANEOUS NERVE EVALUATION VERSUS STAGED SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE. DIS. COLON RECTUM. 2016;59(10):962-967. DOI: 10.1097/DCR.0000000000000668. SUMMARY: SACRAL NEUROMODULATION USING A 2-STAGED APPROACH IS AN ESTABLISHED THERAPY FOR FECAL INCONTINENCE. OFFICE-BASED PERCUTANEOUS NERVE EVALUATION IS A LESS INVASIVE ALTERNATIVE TO THE STAGE 1 PROCEDURE BUT IS SELDOM USED IN THE EVALUATION OF PATIENTS WITH FECAL INCONTINENCE. REPORTED EVENTS IN THE ¿SA¿ GROUP (MEAN AGE = 63, MAJORITY FEMALE): 1 PATIENT WITH SACRAL NEUROSTIMULATION (SNS) FOR FECAL INCONTINENCE EXPERIENCED AN INFECTION WHICH REQUIRED DEVICE EXPLANT; 2 PATIENTS WITH SNS FOR FECAL INCONTINENCE EXPERIENCED AN INFECTION WHICH REQUIRED DEVICE EXPLANT. THE PATIENTS WERE SUBSEQUENTLY ABLE TO HAVE A REPLACEMENT DEVICE; 1 PATIENT WITH SNS FOR FECAL INCONTINENCE EXPERIENCED AN INFECTION WHICH WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS; 1 PATIENT WITH SNS FOR FECAL INCONTINENCE EXPERIENCED AN INFECTION AFTER THE INITIAL TESTING PHASE DURING A 2-STAGED APPROACH TRIAL. THIS INFECTION REQUIRED REMOVAL OF THE TRIAL LEAD AND PREVENTED PERMANENT IMPLANTATION. THE PATIENT THEREFORE FAILED THE TRIAL DESPITE HAVING GREATER THAN 50% IMPROVEMENT IN SYMPTOMS. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3889; IMPLANTABLE NEUROSTIMULATOR INTERSTIM II MODEL 3058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739930 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R