BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 4143968 · Received October 6, 2014

    Report

    Report Number
    3007566237-2014-02850
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_ENS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    JOHNSON, B.L., ABODEELY, A., FERGUSON, M.A., DAVIS, B.R., RAFFERTY, J.F., PAQUETTE, I.M. IS SACRAL NEUROMODULATION HERE TO STAY? CLINICAL OUTCOMES OF A NEW TREATMENT FOR FECAL INCONTINENCE. JOURNAL OF GASTROINTESTINAL SURGERY : OFFICIAL JOURNAL OF THE SOCIETY FOR SURGERY OF THE ALIMENTARY TRACT. 2014. DOI 10.1007/S11605-014-2611-4 SUMMARY: SACRAL NEUROMODULATION (SNM) WAS APPROVED BY THE FDA FOR THE TREATMENT OF FECAL INCONTINENCE (FI) IN 2011, AND PREVIOUS INDUSTRY-SPONSORED TRIALS HAVE SHOWN EXCELLENT CLINICAL OUTCOMES. THE PURPOSE OF THIS STUDY IS TO EXAMINE CLINICAL OUTCOMES OF PATIENTS TREATED DURING OUR INITIAL EXPERIENCE WITH SNM. A PROSPECTIVE DATABASE OF PATIENTS TREATED WITH SNM FOR FI BY ONE OF THREE COLORECTAL SURGEONS AT TWO SEPARATE INSTITUTIONS WAS MAINTAINED STARTING IN 2011. PATIENTS SHOWING =50 % IMPROVEMENT OF WEEKLY INCONTINENT EPISODES DURING TEST STIMULATION WERE OFFERED PERMANENT IMPLANTATION OF THE SNM DEVICE. DISEASE SEVERITY WAS TRACKED USING THE WEXNER SCORE. A TOTAL OF 145 PATIENTS RECEIVED A FULL SYSTEM IMPLANTATION (OF 152 WHO RECEIVED TEST STIMULATION). THE MEDIAN PREOPERATIVE WEXNER SCORE OF 14 DECREASED TO 3, 3 MONTHS AFTER IMPLANTATION AND PERSISTED TO 12 MONTHS. AT 12 MONTHS, 95.2% OF PATIENTS ACHIEVED >50% IMPROVEMENT IN WEXNER SCORE AND 67.6% ACHIEVED >75% IMPROVEMENT. THE MOST COMMON ADVERSE EVENT WAS INFECTION (3.4 %). THREE PATIENTS (2.1%) REQUIRED LEAD REVISION. SNM IS A SAFE AND EFFECTIVE THERAPY FOR THE TREATMENT OF FI. POSTOPERATIVE PATIENT SURVEILLANCE IS IMPORTANT, AS MANY PATIENTS REQUIRE PROGRAMMING CHANGES, AND SOME WILL REQUIRE A LEAD REVISION OVER TIME. REPORTED EVENTS: THREE PATIENTS WERE EXPLANTED DUE TO INFECTION AND WERE RE-IMPLANTED. TWO PATIENTS WERE EXPLANTED DUE TO INFECTION AND THE PATIENT WAS CONSIDERED TO RETURN TO THEIR BASELINE WEXNER SCORE PER STUDY PROTOCOL AS THEY WERE NOT RE-IMPLANTED. ONE PATIENT WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THE RESULTS. THE PATIENT WAS CONSIDERED TO RETURN TO THEIR BASELINE WEXNER SCORE PER STUDY PROTOCOL AS THE PATIENT WAS NOT RE-IMPLANTED. THREE PATIENTS REQUIRED LEAD REVISIONS IN THE OPERATING ROOM. REVISIONS OCCURRED FOR LEAD MALFUNCTION OR LEAD MIGRATION. IN MOST CASES, A TRAUMATIC EVENT EXPERIENCED BY THE PATIENT WAS THE PRECEDING FACTOR. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: UNKNOWN INTERSTIM SYSTEM FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622808 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention