BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 13156108 · Received January 4, 2022

    Report

    Report Number
    2182207-2022-00011
    Event Type
    Injury
    Date Received
    January 4, 2022
    Report Date
    January 4, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEURETTE, G., SIPROUDHIS, L., LEROI, A. M., DAMON, H., KELLER, D. U. J., FAUCHERON, J. L. SACRAL NEUROMODULATION WITH THE INTERSTIM SYSTEM FOR FAECAL INCONTINENCE: RESULTS FROM A PROSPECTIVE FRENCH MULTICENTRE OBSERVATIONAL STUDY. COLORECTAL DIS. 2021. 23(6):1463-1473. DOI: 10.1111/CODI.15507. SUMMARY: TO EVALUATE THE EFFICACY, QUALITY OF LIFE (QOL), PATIENT SATISFACTION AND SAFETY OF SACRAL NEUROMODULATION (SNM) WITH THE INTERSTIMTM SYSTEM FOR THE TREATMENT OF FAECAL INCONTINENCE (FI) AND ESTABLISH WHETHER RESULTS PUBLISHED PREDOMINANTLY BY EXPERT SITES ARE GENERALISABLE. THIS IS A PROSPECTIVE, MULTICENTRE, OBSERVATIONAL STUDY INVITING ALL FRENCH SITES TREATING FI WITH THE INTERSTIM¿ SYSTEM TO ENROLL SUBJECTS FOR SNM THERAPY EVALUATION. DATA WERE COLLECTED AT 3 FOLLOW-UP VISITS WITHIN 1 AND 15 MONTHS. THERAPY EFFICACY WAS EVALUATED BY THE REDUCTION IN LEAKAGES/WEEK AND THE IMPROVEMENTS OVER TIME IN THE ABILITY TO DEFER DEFAECATION AND QOL AS MEASURED WITH THE FIQL SCORE (FAECAL INCONTINENCE QUALITY OF LIFE SCORE). SAFETY WAS ASSESSED THROUGH REPORTED ADVERSE EVENTS. A TOTAL OF 221 SUBJECTS WITH A MEAN AGE OF 62.1 YEARS WERE TESTED (184 FEMALE) AND 178 RECEIVED A PERMANENT IMPLANT. FOR ALL IMPLANTED SUBJECTS WITH DIARY DATA AT BASELINE AND FOLLOW-UP, MORE THAN 50% REDUCTION IN LEAKAGE WAS OBSERVED IN 80%, 76% AND 83% AT 1-3, 4-8 AND 9-15 MONTHS RESPECTIVELY. THE MEAN NUMBER OF LEAKAGE EPISODES AND URGENCY IMPROVED SIGNIFICANTLY COMPARED WITH THE BASELINE (P<(><<)>0.0001). SUBJECTS HAD IMPROVEMENTS IN QOL AND TIME TO DEFER DEFAECATION AND WERE GENERALLY SATISFIED WITH THEIR THERAPY. THE MAIN DEVICE RELATED ADVERSE EVENT WAS THE REQUIREMENT TO UNDERTAKE REPROGRAMMING (IN 52% OF SUBJECTS FOLLOWING AN EVENT). THE RATE OF INFECTION (6%) AND SURGICAL REVISION (10%) WAS IN AGREEMENT WITH LITERATURE REPORTS. CONCLUSION: THIS STUDY CONFIRMS THE CLINICAL EFFICACY, SAFETY AND POSITIVE EFFECT OF SNM ON QOL AS WELL AS HIGH PATIENT SATISFACTION FOR THE TREATMENT OF FI. REPORTED EVENTS: 1. AMONG THE DEVICE OR PROCEDURE-RELATED ADVERSE EVENTS THERE WERE 14 INFECTIONS (13/14 IMPLANT SITE INFECTIONS) WHICH GAVE AN INFECTION RATE OF 6%. EIGHT INFECTIONS OCCURRED BEFORE PERMANENT IMPLANTATION. FIVE OF THOSE SUBJECTS WERE EVENTUALLY PERMANENTLY IMPLANTED AFTER THEY EITHER RECEIVED A NEW LEAD (4) OR WERE TREATED WITH ANTIBIOTICS (1) AND SUBSEQUENTLY COMPLETED THE THERAPY EVALUATION SUCCESSFULLY. OF THE 6 INFECTIONS THAT OCCURRED AFTER PERMANENT IMPLANTATION, 5 INFECTIONS LED TO DEVICE EXPLANTATION AND 1 REQUIRED THE LEAD TO BE REPOSITIONED. 5. IN ADDITION TO THESE, THERE WERE 2 PERMANENT EXPLANTATIONS DUE TO SCIATICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538609 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention