BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 6465191 · Received April 6, 2017

    Report

    Report Number
    3007566237-2017-01327
    Event Type
    Injury
    Date Received
    April 6, 2017
    Date of Event
    July 11, 2016
    Report Date
    April 6, 2017
    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

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID NEU_ENS_STIMULATOR, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID 3023, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_ENS_STIMULATOR, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. 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.

    Description of Event or Problem · 1

    IRWIN, G. W., DASARI, B. V., IRWIN, R., JOHNSTON, D., KHOSRAVIANI, K. OUTCOMES OF SACRAL NERVE STIMULATION FOR FAECAL INCONTINENCE IN NORTHERN IRELAND. ULSTER MEDICAL JOURNAL. 2017. 86(1): 20-24. SUMMARY: SACRAL NERVE ROOT STIMULATION (SNS) IS AN EFFECTIVE AND DEVELOPING THERAPY FOR FAECAL INCONTINENCE, A DEBILITATING CONDITION THAT CAN RESULT IN SOCIAL AND PERSONAL INCAPACITATION. THE OBJECTIVES OF THIS STUDY ARE TO ASSESS THE MORBIDITY OF THE PROCEDURE, IMPROVEMENT IN THE INCONTINENCE SCORES AND QUALITY OF LIFE (QOL) FOLLOWING SNS. PATIENTS WERE IDENTIFIED FROM THE NORTHERN IRELAND REGIONAL SNS SERVICE FROM 2006 TO 2012. NUMBERS OF PATIENTS WHO HAD TEMPORARY PLACEMENT AND PERMANENT PLACEMENT WERE COLLATED. PRE AND POSTOPERATIVE ASSESSMENT OF SEVERITY OF INCONTINENCE AND QOL WAS PERFORMED USING CLEVELAND CLINIC INCONTINENCE SCORE (CCIS) AND SHORT FORM-36 (SF-36) RESPECTIVELY. STATISTICAL ANALYSIS WAS UNDERTAKEN USING WILCOXON SIGNED RANK TEST. MORBIDITY WAS ASSESSED BY RETROSPECTIVE REVIEW OF PATIENT RECORDS. SEVENTY-FIVE PATIENTS WERE CONSIDERED FOR TRIAL OF A TEMPORARY SNS. SIXTY-ONE PROCEEDED TO INSERTION OF A TEMPORARY SNS AND, OF THESE, 40 ELECTED TO HAVE A PERMANENT SNS. THERE WAS A SIGNIFICANT REDUCTION IN THE PRE-SNS AND POST-SNS CLEVELAND CLINIC INCONTINENCE SCORES FROM MEDIAN OF 14 TO 9 RESPECTIVELY (P=0.008). THERE WAS A SIGNIFICANT IMPROVEMENT IN ROLE PHYSICAL (P=0.017), GENERAL HEALTH (P=0.02), VITALITY (P=0.043), SOCIAL FUNCTIONING (P=0.004), ROLE EMOTIONAL (P=0.007), MENTAL HEALTH (P=0.013) AND MENTAL HEALTH SUMMARY (P=0.003). HOWEVER, THIS IS NOT REFLECTED IN THE BODILY PAIN AND PHYSICAL FUNCTIONAL DOMAINS. PERMANENT SACRAL NERVE STIMULATION IS EFFECTIVE AND RESULTS IN SIGNIFICANT IMPROVEMENT OF FAECAL INCONTINENCE SCORES AND QUALITY OF LIFE. REPORTED EVENTS: APPROX 5 PATIENTS IMPLANTED FOR SACRAL NERVE ROOT STIMULATION INITIALLY WERE UNDER THE SUSPICION OF AN INFECTION. THE PATIENTS WERE GIVEN ANTIBIOTICS FOR ERYTHEMA AROUND THE WOUND; APPROX 1 PATIENT IMPLANTED FOR SACRAL NERVE ROOT STIMULATION INITIALLY WAS UNDER THE SUSPICION OF AN INFECTION THAT EXPERIENCED WOUND BREAKDOWN. THE STIMULATOR HAD TO BE REPLACED DUE TO THE INFECTION; APPROX 1 PATIENT IMPLANTED FOR SACRAL NERVE ROOT STIMULATION WAS FOUND TO HAVE A STERILE ABSCESS; APPROX 1 PATIENT IMPLANTED FOR SACRAL NERVE ROOT STIMULATION EXPERIENCED A WIRE FAILURE AND THE DEVICE HAD TO BE REPOSITIONED. THE PATIENT HAD NO CHANGE IN THEIR CLEVELAND CLINIC INCONTINENCE SCORE (CCIS) AT 6 WEEKS; APPROX 1 PATIENT IMPLANTED FOR SACRAL NERVE ROOT STIMULATION EXPERIENCED A BATTERY FAILURE AFTER THE DEVICE HAD BEEN IN PLACE FOR OVER FIVE YEARS. THE DEVICE HAD TO BE REPOSITIONED. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: INS MODEL 3023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246767 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3023 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R