BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3702196 · Received March 26, 2014

    Report

    Report Number
    3007566237-2014-00822
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    April 27, 2013
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3889, PRODUCT TYPE LEAD, PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE LEAD, PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE LEAD, PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3889, PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_ENS_STIMULATOR, (B)(4), PRODUCT TYPE EXTERNAL NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    MOYA, P., ARROYO, A., LACUEVA, J. CANDELA, F., SORIANO-IRIGARAY, L., LOPEZ, A., GOMEZ, M.A., GALINDO, I., CALPENA, R. SACRAL NERVE S TIMULATION IN THE TREATMENT OF SEVERE FAECAL INCONTINENCE: LONG-TERM CLINICAL, MANOMETRIC AND QUALITY OF LIFE RESULTS. TECHNIQUES IN COLOPROCTOLOGY. 2014;18(2):179-185. DOI 10.1007/S10151-013-1022-Y SUMMARY: FAECAL INCONTINENCE (FI) IS A COMPLEX AND MULTIFACTORIAL HEALTH PROBLEM. TREATMENT HAS TO BE INDIVIDUALISED, ANALYSING THE AETIOLOGY AND GRAVITY IN EVERY CASE. SACRAL NERVE STIMULATION (SNS) HAS BEEN SHOWN TO EFFECTIVELY IMPROVE TREATMENT OF FI. FIFTY PATIENTS WITH SEVERE FI TREATED WITH SNS BETWEEN MARCH 2002 AND DECEMBER 2010 WERE ANALYSED. PREOPERATIVE ASSESSMENT INCLUDED PHYSICAL EXAMINATION, ANORECTAL MANOMETRY AND ANAL ENDOSONOGRAPHY. ANAL CONTINENCE WAS EVALUATED USING THE WEXNER CONTINENCE GRADING SYSTEM. QUALITY OF LIFE WAS EVALUATED USING THE FECAL INCONTINENCE QUALITY OF LIFE SCALE (FIQLS). FOLLOWUP APPOINTMENTS WERE SCHEDULED AT 1, 6 AND 12 MONTHS AND ANNUALLY THEREAFTER. WEXNER SCORE, FIQLS AND THE ABILITY TO DEFER DEFECATION WERE ASSESSED AT EACH VISIT. FIFTY PATIENTS UNDERWENT A PERMANENT IMPLANT. THE OVERALL MEAN FOLLOW-UP PERIOD WAS 55.52 ± 31.84 MONTHS. AFTER 6 MONTHS, SNS SIGNIFICANTLY IMPROVED FI AND POSITIVELY IMPACTED QUALITY OF LIFE, AS EVIDENCE BY SIGNIFICANT IMPROVEMENTS IN ALL 4 SCALES OF THE FIQLS. ANORECTAL MANOMETRY SHOWED A TREND TOWARDS AN INCREASE IN MAXIMUM RESTING PRESSURE AND MAXIMUM PRESSURE. AFTER THE FIRST ASSESSMENT AT 6 MONTHS, WEXNER SCORE AND FIQLS REMAINED STABLE. ABILITY TO DEFER DEFECATION WAS ALSO MAINTAINED. DURING FOLLOW-UP, 3 PATIENTS (6 %) EXPERIENCED IMPLANT SITE PAIN AND EPISODES OF EXTREMITY PAIN AND PARESTHESIAS THAT WERE REFRACTORY TO MEDICAL MANAGEMENT AND REQUIRED DEVICE EXPLANTATION. THE IMPLANT SITE INFECTION RATE WAS 2 %. ANALYSIS OF OUR LONG-TERM RESULTS CONFIRMS THE SAFETY AND EFFECTIVENESS OF SNS IN THE MANAGEMENT OF PATIENTS WITH FI. REPORTED EVENTS: 1. 2 PATIENTS EXPERIENCED IMPLANT SITE INFECTION, WHICH REQUIRED DEVICE EXPLANT, ANTIBIOTIC TREATMENT, AND NEW IMPLANTATION TWO MONTHS AFTER THE DEVICE WAS REMOVED. 2. 3 PATIENTS EXPERIENCED IMPLANT SITE PAIN AND EPISODES OF EXTREMITY PAIN AND PARESTHESIAS THAT WERE REFRACTORY TO MEDICAL MANAGEMENT AND REQUIRED DEVICE EXPLANTATION. 3. 1 PATIENT EXPERIENCED A SUDDEN WORSENING OF THE FUNCTIONAL RESULTS FOLLOWING A FALL BECAUSE THE ELECTRODE WAS BROKEN WITHOUT DISPLACEMENT. THE REPORTER STATED THAT A NEW ELECTRODE WAS SUCCESSFULLY IMPLANTED UNDER LOCAL ANESTHESIA. 4. 1 PATIENT EXPERIENCED A SUDDEN WORSENING OF THE FUNCTIONAL RESULTS OF SACRAL NERVE STIMULATION (SNS) BECAUSE THE ELECTRODE WAS BROKEN WITH DISPLACEMENT AFTER A VAGINAL DELIVERY. THE REPORTER STATED THAT A NEW ELECTRODE WAS SUCCESSFULLY IMPLANTED UNDER LOCAL ANESTHESIA. 5. LESS THAN 4 PATIENTS EXPERIENCED LEAD DISPLACEMENT DURING THE PERIPHERAL NERVE EVALUATION (PNE). FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176943 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention