BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 6089999 · Received November 9, 2016

    Report

    Report Number
    3007566237-2016-03990
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS WITHIN THE PNE GROUP REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS WITHIN THE PNE GROUP REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. 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 PUBLICATION DATE WAS NOT PROVIDED (ONLY THE YEAR). INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3057, LOT# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3057, LOT# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3057, LOT# UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3058, LOT# UNKNOWN, 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

    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 S TIMULATION 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 EVENT IN THE PNE GROUP: 1 PATIENT WITH SACRAL NEUROSTIMULATION (SNS) FOR FECAL INCONTINENCE EXPERIENCED LEAD MIGRATION DURING THE PERCUTANEOUS NERVE EVALUATION (PNE) AND OPTED NOT TO UNDERGO ADDITIONAL STAGED-APPROACH TESTING. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED FOR THIS GROUP IN THE ARTICLE: LEAD MODEL 3057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741007 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR