BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3025718 · Received March 28, 2013

    Report

    Report Number
    3007566237-2013-00935
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    August 12, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: NEU_ENS_STIMULATOR, SERIAL#: UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL#: UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 3023, SERIAL#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    DAMON, H., BARTH, X., ROMAN, S., MION, F. SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE IMPROVES SYMPTOMS, QUALITY OF LIFE AND PATIENTS' SATISFACTION: RESULTS OF A MONOCENTRIC SERIES OF 119 PATIENTS. INT. J. COLORECTAL DIS. 2013;28(2):227-233. DOI: 10.1007/S00384-012-1558-8. SUMMARY: SACRAL NERVE STIMULATION (SNS) IS VALIDATED AS AN EFFICIENT TREATMENT FOR FECAL INCONTINENCE (FI). HOWEVER, LONG-TERM RESULTS ARE SCARCE IN THE LITERATURE. THE GOAL OF THIS STUDY WAS TO ASSESS THE IMPACT OF SNS ON FI SYMPTOMS AND QUALITY OF LIFE, BASED ON A RETROSPECTIVE ANALYSIS OF PROSPECTIVELY COLLECTED DATA. FROM 2001 TO 2009, 119 PATIENTS (SIX MEN, MEAN AGE 61 YEARS) UNDERWENT SNS TESTING FOR FI AFTER AN EXTENSIVE DIAGNOSTIC WORKUP. PERMANENT IMPLANTATION WAS REALIZED WHEN FI SYMPTOMS IMPROVED DURING TESTING, AND FOLLOW-UP VISITS WERE PERFORMED EVERY 12 MONTHS THEREAFTER. THIS FOLLOW-UP EVALUATED MORBIDITY AND EFFICACY,BASED ON CLINICAL DATA AND SELF-ADMINISTERED QUESTIONNAIRES INCLUDING JORGE AND WEXNER FI SCORE, URINARY INCONTINENCE SCORE (URINARY DISTRESS INVENTORY-6, UDI-6), GASTROINTESTINAL QUALITY OF LIFE INDEX (GIQLI), AND AUTO-EVALUATION SCALE. A PERMANENT STIMULATOR WAS IMPLANTED AFTER A POSITIVE TEST IN 102 PATIENTS (91 %). TEN PATIENTS WERE EXPLANTED DURING FOLLOW-UP (PAIN IN ONE CASE AND ABSENCE OF EFFICACY IN NINE), AND 29 HAD THE STIMULATOR AND/OR THE ELECTRODE CHANGED. THE MEAN FOLLOW-UP WAS 48 MONTHS (RANGE 12 - 84): THERE WAS A SIGNIFICANT IMPROVEMENT OF FI SCORE (9±1 VS 14±3, P<(><<)>0.0001), UDI-6 SCORE (8±4 VS 11±5, P<(><<)>0.05), AND GIQLI INDEX (P<(><<)>0.002). THE IMPROVEMENT WAS PRESENT AT 12 MONTHS FOLLOW-UP AND REMAINED STABLE. EIGHTY PERCENT OF PATIENTS WERE SATISFIED WITH THE TREATMENT AT THE LAST POINT OF FOLLOW-UP. NONE OF THE PRETREATMENT VARIABLES WERE PREDICTIVE OF SNS EFFICACY. SNS IMPROVED FI AND QUALITY OF LIFE, AND THIS EFFICACY REMAINED OVER TIME. ALTHOUGH A COMPLETE DISAPPEARANCE OF FI WAS RARE, MOST PATIENTS WERE SATISFIED. REPORTED EVENTS: 1 PATIENT EXPERIENCED SEVERE PAIN AND HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED; 9 PATIENTS EXPERIENCED A LOSS OF EFFICACY AND HAD THEIR INS EXPLANTED; 1 PATIENT EXPERIENCED SEPSIS AND HAD THE INS REMOVED; 1 PATIENT HAD THE INS REPOSITIONED TO THE OPPOSITE BUTTOCK WITHOUT COMPLICATION; 1 PATIENT EXPERIENCED A SEVERE NICKEL ALLERGY AFTER THE ELECTRODE BROKE. THE INS AND ELECTRODE WERE EXPLANTED AND A NEW INS AND ELECTRODE WERE IMPLANTED ON THE OPPOSITE SIDE; 6 PATIENTS EXPERIENCED ELECTRODE DISPLACEMENT AND THE ELECTRODES WERE REPLACED; 2 PATIENTS EXPERIENCED BROKEN ELECTRODES. THE ELECTRODES WERE REPLACED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128264 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention