BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 6800263 · Received August 17, 2017

    Report

    Report Number
    3007566237-2017-03331
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    April 27, 2017
    Report Date
    July 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    D'HONDT, M., NUYTENS, F., KINGET, L., DECAESTECKER, M., BORGERS, B., PARMENTIER, I. SACRAL NEUROSTIMULATION FOR LOW ANTERIOR RESECTION SYNDROME AFTER RADICAL RESECTION FOR RECTAL CANCER: EVALUATION OF TREATMENT WITH THE LARS SCORE. TECH COLOPROCTOL. 2017.21(4):301-307. DOI: 10.1007/S10151-017-1612-1 SUMMARY: SACRAL NEUROSTIMULATION (SNS) HAS PROVEN TO BE AN EFFECTIVE TREATMENT MODALITY FOR LOW ANTERIOR RESECTION SYNDROME (LARS). THE PRIMARY AIM OF THIS STUDY IS TO INVESTIGATE THE IMPACT OF SNS ON ALL SYMPTOMS OF LARS, NOT MERELY ON FECAL INCONTINENCE. FURTHERMORE, WE WANTED TO EVALUATE WHETHER THE LARS SCORE COULD BE USEFUL AS A TOOL TO EVALUATE SNS TREATMENT. ALL PATIENTS DIAGNOSED WITH MINOR OR MAJOR LARS, UNRESPONSIVE TO CONSERVATIVE THERAPY FOR FECAL INCONTINENCE, WHO UNDERWENT SACRAL NEUROMODULATION FOR LARS AT GROENINGE HOSPITAL, KORTRIJK, BELGIUM, WERE PROSPECTIVELY ENROLLED IN THE STUDY. THE PRIMARY ENDPOINT WAS THE REDUCTION IN THE SEVERITY OF LARS. THIS WAS ASSESSED BY VALIDATED QUESTIONNAIRES: THE LARS SCORE AND THE WEXNER SCORE. ELEVEN PATIENTS UNDERWENT DEFINITE IMPLANTATION OF THE SNS DEVICE. ALL PATIENTS SHOWED A SUBSTANTIAL DECREASE IN THEIR WEXNER SCORES: THE MEAN SCORE WAS REDUCED FROM 17.7 TO 4.6 (Z: 2.93; P: 0.0033). ADDITIONALLY, THE MEAN LARS SCORE DROPPED FROM 36.9 TO 11.4 (Z: 2.93; P: 0.0033). FURTHERMORE, THERE WAS A SIGNIFICANT AMELIORATION OF ALL SYMPTOMS OF LARS. OUR STUDY SHOWS THAT SNS IS EFFECTIVE FOR ALL SYMPTOMS OF LARS. THE AUTHORS BELIEVE THAT IN PATIENTS WHO RECEIVE SNS FOR LARS, IT COULD BE USEFUL TO DETERMINE THE LARS SCORE TO EVALUATE THE COMPLEXITY OF THE SYMPTOMS AND THEIR RESPONSE TO TREATMENT. REPORTED EVENT: A POSTOPERATIVE COMPLICATION OCCURRED IN ONE CASE IN WHICH THE PATIENT EXPERIENCED PAIN BECAUSE THE BATTERY OF THE NEUROSTIMULATOR HAD MIGRATED TOWARD THE SUPERFICIAL SUBCUTANEOUS TISSUE. UNDER GENERAL ANESTHESIA, THE BATTERY WAS REPOSITIONED DEEPER AND MORE CAUDAL WHICH RESULTED IN NO FURTHER DISCOMFORT. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582196 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention