BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 13181608 · Received January 6, 2022

    Report

    Report Number
    2182207-2022-00032
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    November 30, 2021
    Report Date
    January 6, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DUCHALAIS. E., DRISSI, F., DELESTRE. M., WYART. V., LEHUR. PA., MEURETTE. G. LONG-TERM RESULTS OF SACRAL NEUROMODULATION FOR THE TRE ATMENT OF ANORECTAL DISEASES. J VISC SURG. 2021. DOI:10.1007/S00192-019-04208-0 SUMMARY: SACRAL NEUROMODULATION (SNM) AIMS TO IMPROVE ANORECTAL FUNCTION IN PATIENTS WITH DISORDERS OF ANAL CONTINENCE AND RECTAL EMPTYING. THE MECHANISM OF ACTION OF SNM IS NOT WELL, KNOWN, AND ITS INDICATIONS ARE STILL UNDER EVALUATION. WE REPORT THE FUNCTIONAL RESULTS AND MORBIDITY OF A PROSPECTIVE COHORT TREATED BETWEEN 2002 AND 2019. A TOTAL OF 284 PATIENTS (OF 423 TESTED) HAD IMPLANTATION OF A SNM. FIVE PATIENTS (1.8%) WERE LOST TO FOLLOW-UP. AMONG THOSE WHO HAD IMPLANTATION, THE INDICATIONS FOR SNM WERE ANAL INCONTINENCE (N = 376), REFRACTORY CONSTIPATION (N = 17), ANTERIOR RESECTION SYNDROME (N = 13), SOLITARY RECTAL ULCER SYNDROME (N = 7), AND CHRONIC INFLAMMATORY BOWEL DISEASE (IBD) (N = 10). THE MORBIDITY RATE WAS 2.7% (DINDO¿CLAVIEN > 2), 33 PATIENTS (11%) REQUIRED EXPLANTATION FOR INFECTION (N = 5), PAIN (N = 2), INEFFICACY (N = 24) OR OTHER REASONS (RECTAL CANCER) (N = 3). IT WAS NECESSARY TO CHANGE THE STIMULATOR IN 68 PATIENTS (24%) DURING THE FOLLOW-UP PERIOD. REGARDING THE GROUP OF PATIENTS WITH ANAL INCONTINENCE, FUNCTIONAL RESULTS SHOWED IMPROVEMENT OF THE INCONTINENCE SCORE IN 40% AND OF QUALITY OF LIFE IN 25% AFTER A MEAN FOLLOW-UP OF 55 MONTHS. SNM CONSTITUTES A MINI-INVASIVE TREATMENT ASSOCIATED WITH LOW MORBIDITY. ITS¿ EFFICACY IN ANAL INCONTINENCE MAKES IT A PRIORITY APPROACH. OTHER INDICATIONS ARE STILL UNDER EVALUATION: WHILE RESULTS ARE PROMISING, THEY ARE HIGHLY VARIABLE. REPORTED EVENTS: 5 PATIENTS REQUIRED REPOSITION OF THE LEAD NO SPECIFIC DEVICE INFORMATION PROVIDED FOR THE LEAD BUT INS MODEL WAS PROVIDED 3058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041046 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention