BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3240613 · Received July 22, 2013

    Report

    Report Number
    3007566237-2013-02422
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    October 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR; PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    MELLGREN, A., WEXNER, S. D., COLLER, J. A., DEVROEDE, G., LEREW, D. R., MADOFF, R. D., HULL, T. LONG-TERM EFFICACY AND SAFETY OF SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE. DISEASES OF THE COLON AND RECTUM. 2011;54(9):1065-1075. DOI: 10.1097/DCR.0B013E31822155E9. SUMMARY: PATIENTS WITH FECAL INCONTINENT EPISODES MORE THAN TWICE PER WEEK WERE OFFERED PARTICIPATION IN THIS MULTICENTEREDPROSPECTIVE TRIAL. PATIENTS SHOWING >50% IMPROVEMENT DURING TEST STIMULATION WERE OFFERED CHRONIC IMPLANTATION OF THE INTERSTIM THERAPY SYSTEM (MEDTRONIC; MINNEAPOLIS, MN). THE AIMS OF THE CURRENT REPORT WERE TO PROVIDE 3-YEAR FOLLOW-UP DATA ON PATIENTS FROM THAT STUDY WHO UNDERWENT SACRAL NERVE STIMULATION AND WERE MONITORED UNDER THE RIGORS OF AN FOOD AND DRUG ADMINISTRATION APPROVED INVESTIGATIONAL PROTOCOL. ONE HUNDRED THIRTY-THREE PATIENTS UNDERWENT TEST STIMULATION WITH A 90% SUCCESS RATE, OF WHOM 120 (110 FEMALES) WITH A MEAN AGE OF 60.5 YEARS AND A MEAN DURATION OF FECAL INCONTINENCE OF 7 YEARS RECEIVED CHRONIC IMPLANTATION. MEAN LENGTH OF FOLLOW-UP WAS 3.1 (RANGE, 0.2¿ 6.1) YEARS, WITH 83 PATIENTS COMPLETING ALL OR PART OF THE 3-YEAR FOLLOW-UP ASSESSMENT. AT 3 YEARS FOLLOW-UP, 86% OF PATIENTS (P _ .0001) REPORTED >50% REDUCTION IN THE NUMBER OF INCONTINENT EPISODES PER WEEK COMPARED WITH BASELINE AND THE NUMBER OF INCONTINENT EPISODES PER WEEK DECREASED FROM A MEAN OF 9.4 AT BASELINE TO 1.7. PERFECT CONTINENCE WAS ACHIEVED IN 40% OF SUBJECTS. THE THERAPY ALSO IMPROVED THE FECAL INCONTINENCE SEVERITY INDEX. SACRAL NERVE STIMULATION HAD A POSITIVE IMPACT ON THE QUALITY OF LIFE, AS EVIDENCED BY SIGNIFICANT IMPROVEMENTS IN ALL 4 SCALES OF THE FECAL INCONTINENCE QUALITY OF LIFE INSTRUMENT AT 12, 24, AND 36 MONTHS OF FOLLOW-UP. THE MOST COMMON DEVICE- OR THERAPY-RELATED ADVERSE EVENTS THROUGH THE MEAN 36 MONTHS OF FOLLOW-UP INCLUDED IMPLANT SITE PAIN (28%), PARESTHESIA (15%), CHANGE IN THE SENSATION OF STIMULATION (12%), AND INFECTION (10%). THERE WERE NO REPORTED UNANTICIPATED ADVERSE DEVICE EFFECTS ASSOCIATED WITH SACRAL NERVE STIMULATION THERAPY. REPORTED EVENTS: 5 PATIENTS HAD AN INFECTION THAT REQUIRED DEVICE EXPLANTATION. IT WAS NOTED THAT THE CONSEQUENCES OF THE INFECTION WERE CONTROLLED AND DID NOT LEAD TO ANY PERMANENT MORBIDITY. ONE PATIENT HAD AN INFECTION THAT REQUIRED DEVICE EXPLANTATION AND REPLACEMENT. IT WAS NOTED THAT THE CONSEQUENCES OF THE INFECTION WERE CONTROLLED AND DID NOT LEAD TO ANY PERMANENT MORBIDITY. FIVE PATIENTS HAD AN INFECTION THAT RESOLVED WITH MEDICATION. IT WAS NOTED THAT THE CONSEQUENCES OF THE INFECTION WERE CONTROLLED AND DID NOT LEAD TO ANY PERMANENT MORBIDITY. ONE PATIENT HAD AN INFECTION WHICH OCCURRED DURING THE TEST STIMULATION PHASE. IT WAS NOTED THAT THE CONSEQUENCES OF THE INFECTION WERE CONTROLLED AND DID NOT LEAD TO ANY PERMANENT MORBIDITY. TWO PATIENTS HAD AN INFECTION AT THE IMPLANT SITE. THREE PATIENTS EXPERIENCED A FAILURE OF THE ACUTE TEST STIMULATION. ONE PATIENT HAD A SUSPECTED DEVICE PROBLEM. ONE PATIENT HAD RECTAL PROLAPSE; 18 PATIENTS HAD PAIN AT THE IMPLANT SITE. IT WAS NOTED THAT TREATMENT FOR THIS INCLUDED MEDICATION, NEUROSTIMULATOR AND LEAD EXPLANT, AND NEUROSTIMULATOR REVISION. 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
    341271 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention