BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 6798699 · Received August 16, 2017

    Report

    Report Number
    3007566237-2017-03320
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    April 20, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. 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. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MAEDA, Y., KAMM, M. A., VAIZEY, C. J., MATZEL, K. E., JOHANSSON, C., ROSEN, H., BAETEN, C. G., LAURBERG, S. LONG-TERM OUTCOME OF SACRAL NEUROMODULATION FOR CHRONIC REFRACTORY CONSTIPATION. TECH COLOPROCTOL. 2017. 21(4): 277-286. DOI 10.1007/S10151-017-1613-0 SUMMARY: SACRAL NEUROMODULATION HAS BEEN REPORTED AS A TREATMENT FOR SEVERE IDIOPATHIC CONSTIPATION. THIS STUDY AIMED TO EVALUATE THE LONG-TERM EFFECTS OF SACRAL NEUROMODULATION BY FOLLOWING PATIENTS WHO PARTICIPATED IN A PROSPECTIVE, OPEN-LABEL, MULTICENTRE STUDY UP TO 5 YEARS. PATIENTS WERE FOLLOWED UP AT 1, 3, 6, 12, 24, 36, 48 AND 60 MONTHS. SYMPTOMS AND QUALITY OF LIFE WERE ASSESSED USING BOWEL DIARY, THE CLEVELAND CLINIC CONSTIPATION SCORE AND THE SHORT FORM-36 QUALITY-OF-LIFE SCALE. SIXTY-TWO PATIENTS (7 MALE, MEDIAN AGE 40 YEARS) UNDERWENT TEST STIMULATION, AND 45 PROCEEDED TO PERMANENT IMPLANTATION. TWENTY-SEVEN PATIENTS EXITED THE STUDY (7 WITHDRAWN CONSENT, 7 LOSS OF EFFICACY, 6 SITE-SPECIFIC REASONS, 4 WITHDREW OTHER REASONS, 2 LOST TO FOLLOW-UP, 1 PRIOR TO FOLLOW-UP). EIGHTEEN PATIENTS (29%) ATTENDED 60-MONTH FOLLOW-UP. IN 10 PATIENTS WHO SUBMITTED BOWEL DIARY, THEIR IMPROVEMENT OF SYMPTOMS WAS SUSTAINED: THE NUMBER OF DEFECATIONS PER WEEK (4.1 ± 3.7 VS 8.1 ± 3.4, MEAN ± STANDARD DEVIATION, P\0.001, BASELINE VS 60 MONTHS) AND SENSATION OF INCOMPLETE EMPTYING (0.8 ± 0.3 VS 0.2 ± 0.1, P = 0.002). IN 14 PATIENTS (23%) WITH CLEVELAND CLINIC CONSTIPATION SCORE, IMPROVEMENT WAS SUSTAINED AT 60 MONTHS [17.9 ± 4.4 (BASELINE) TO 10.4 ± 4.1, P\0.001]. SOME 103 DEVICE-RELATED ADVERSE EVENTS WERE REPORTED IN 27 (61%). BENEFIT FROM SACRAL NEUROMODULATION IN THE LONG-TERM WAS OBSERVED IN A SMALL MINORITY OF PATIENTS WITH INTRAC TABLE CONSTIPATION. THE RESULTS SHOULD BE INTERPRETED WITH CAUTION GIVEN THE HIGH DROPOUT AND COMPLICATION RATE DURING THE FOLLOW-UP PERIOD. REPORTED EVENTS: 1. ONE PATIENT WITH CHRONIC REFRACTORY CONSTIPATION EXPERIENCED AN IMPLANT INFECTION AROUND THE IMPLANTED DEVICE. 2. 6 ADVERSE EVENTS OCCURRED IN 22 OF THE TESTED PATIENTS PRIOR TO THE DEFINITIVE IPG WERE CLASSIFIED AS SERIOUS. 3. 58 ADVERSE EVENTS OCCURRED IN 20 OF THE TESTED PATIENTS WITH CHRONIC REFRACTORY CONSTIPATION WERE CLASSIFIED AS SERIOUS. 4. 6 SERIOUS ADVERSE EVENTS RELATED TO THE DEVICE OCCURRED DURING THE TEST PERIOD. 5. 17 SERIOUS ADVERSE EVENTS RELATED TO THE DEVICE OCCURRED IN 10 PATIENTS AFTER THE DEVICE WAS IMPLANTED. 6. ONE PATIENT HAD INFECTION AT CONNECTION BETWEEN THE TINED LEAD AND CONNECTOR TO EXTENSION LEAD WHICH EVENTUALLY LED TO WITHDRAWAL FROM THE STUDY. 7. 4 PATIENTS EXPERIENCED A SYSTEM MODIFICATION DUE TO A LEAD MIGRATION. 8. 2 PATIENTS EXPERIENCED AN INFECTION REQUIRING A SYSTEM MODIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579373 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R