BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 14717018 · Received June 16, 2022

    Report

    Report Number
    2182207-2022-01111
    Event Type
    Injury
    Date Received
    June 16, 2022
    Report Date
    June 16, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID: NEU_INTERSTIM_INS LOT# UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DESPREZ ,C., DAMON, H., MEURETTE, G., ET AL. TEN-YEAR EVALUATION OF A LARGE RETROSPECTIVE COHORT TREATED BY SACRAL NERVE MODULATION FOR FECAL INCONTINENCE: RESULTS OF A FRENCH MULTICENTER STUDY. ANN SURG. 2022. 275 (4):735-742. DOI: 10.1097/SLA.0000000000004251 SUMMARY: THE AIM OF THIS STUDY WAS TO ASSESS THE EFFECTIVENESS OF SACRAL NERVE MODULATION (SNM) IN A LARGE COHORT OF PATIENTS IMPLANTED FOR AT LEAST 10 YEARS, QUANTIFY ADVERSE EVENT RATES, AND IDENTIFY PREDICTIVE FACTORS OF LONGTERM SUCCESS.FEW STUDIES HAVE EVALUATED THE LONG-TERM SUCCESS OF SNM. DATA COLLECTED PROSPECTIVELY FROM PATIENTS IMPLANTED FOR FECAL INCONTINENCE (FI) IN 7 FRENCH CENTERS BETWEEN JANUARY 1998 AND DECEMBER 2008 WERE RETROSPECTIVELY ANALYZED. PATIENT FI SEVERITY SCORES WERE ASSESSED BEFORE AND 10 YEARS AFTER IMPLANTATION. THE MAIN EVALUATION CRITERION WAS THE SUCCESS OF SNM DEFINED BY THE CONTINUATION OF THE TREATMENT WITHOUT ADDITIONAL THERAPIES. THE SECONDARY EVALUATION CRITERIA WERE THE RATE OF DEVICE REVISIONS AND EXPLANTATIONS. PREOPERATIVE PREDICTORS OF SUCCESS AT 10 YEARS WERE SOUGHT. OF THE 360 PATIENTS (27 MALES, MEAN AGE: 59 _ 12 YEARS) IMPLANTED FOR FI, 162 (45%) HAD A FAVORABLE OUTCOME 10 YEARS POST-IMPLANTATION, 115 (31.9%) FAILED, AND 83 (23.1%) WERE LOST TO FOLLOW-UP. THE FAVORABLE OUTCOME DERIVED FROM THE TIME-TO-EVENT KAPLAN-MEIER CURVE AT 10 YEARS WAS 0.64 (95% CI 0.58¿0.69). FI SEVERITY SCORES WERE SIGNIFICANTLY BETTER 10 YEARS POST-IMPLANTATION COMPARED TO PREIMPLANTATION (7.4 _ 4.3 VS 14.0 _3.2; P<(><<)>0.0001).DURING THE 10-YEAR FOLLOW-UP, 233 PATIENTS (64.7%) HAD A SURGICAL REVISION AND 94 (26.1%) WERE EXPLANTED. A HISTORY OF SURGERY FOR FI AND SEX (MALE) WERE ASSOCIATED WITH AN INCREASED RISK OF AN UNFAVORABLE OUTCOME. LONG-TERM EFFICACY WAS MAINTAINED IN APPROXIMATELY HALF OF THE FI PATIENTS TREATED BY SNM AT LEAST 10 YEARS POST-IMPLANTATION. REPORTED EVENTS: 1. BATTERY DEPLETION WAS THE MAIN ADVERSE EVENT NOTED AND OCCURRED IN 179 PATIENTS (49.7%), WITH SURGICAL REVISIONS REQUIRED IN ALL CASES. 2. THE INTERSTIM I STIMULATOR HAD A MEAN BATTERY LIFE OF 6.5 _2.5 YEARS. LOSS OF EFFICACY WAS THE SECOND MOST IMPORTANT ADVERSE EVENT, AFFECTING 83 PATIENTS (23.1%) AND LEADING TO SURGICAL REVISION OF THE DEVICE IN 35 PATIENTS (9.7%) AND EXPLANTATION IN 53 (14.7%). 3. PAIN OCCURRED IN 64 PATIENTS (17.8%), WITH SURGICAL REVISION IN 32 PATIENTS (8.9%) AND EXPLANTATION IN 28 (7.8%). 4. A PACEMAKER DYSFUNCTION WAS NOTED IN 42 PATIENTS (11.7%), LEADING TO SURGICAL REVISION IN 35 PATIENTS (9.7%) AND EXPLANTATION IN 6 (1.7%). 5. TWENTY-EIGHT PATIENTS (7.8%) HAD AN INFECTION AROUND THE DEVICE, WHICH WAS TREATED BY SURGICAL REVISION IN 11 PATIENTS (3.1%) AND EXPLANTATION IN 18 (5%). 6. ELECTRODE/STIMULATOR DISPLACEMENT OCCURRED IN 28 PATIENTS (7.8%), WHICH WAS CORRECTED BY SURGICAL REVISION IN ALL 28 PATIENTS. 7. LASTLY, SKIN ULCERATION OCCURRED IN 6 PATIENTS (1.7%), LEADING TO SURGICAL REVISION IN 4 PATIENTS (1.1%) AND EXPLANTATION IN 2 (0.6%). SEE ATTACHED LITERATURE ARTICLE. NO SPECIFIC DEVICE INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254934 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention