BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3546646 · Received January 2, 2014

    Report

    Report Number
    3007566237-2014-00007
    Event Type
    Injury
    Date Received
    January 2, 2014
    Report Date
    December 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID 3023, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3023, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3023, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3023, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3625, LOT # UNKNOWN, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    BENSON-COOPER, S., DAVENPORT, E., BISSETT, I. P. INTRODUCTION OF SACRAL NEUROMODULATION FOR THE TREATMENT OF FAECAL INCONTINENCE. THE NEW ZEALAND MEDICAL JOURNAL. SUMMARY: FAECAL INCONTINENCE (FI) IS A CONDITION THAT IMPAIRS QUALITY OF LIFE AND ABILITY TO FUNCTION SOCIALLY. OVER THE LAST 15 YEARS A PROMISING NEW THERAPY (SACRAL NEUROMODULATION, SNM) HAS BEEN INTRODUCED WHICH HAS BEEN ASSOCIATED WITH MARKED IMPROVEMENT IN MANY INCONTINENCE SYMPTOMS. TO ASSESS THE EARLY RESULTS OF (B)(4) IN (B)(4) IN TERMS OF IMPROVED CONTINENCE IN THOSE UNDERGOING IMPLANTATION OF A PERMANENT STIMULATOR, AND DETERMINE WHETHER THESE RESULTS ARE COMPARABLE TO OVERSEAS DATA. PATIENTS WHO MET THE CRITERIA FOR SNM; SEVERE FAECAL INCONTINENCE, FAILURE TO RESPOND TO OTHER MEASURES INCLUDING BIOFEEDBACK, DIETARY MODIFICATIONS, AND APPROPRIATE SURGICAL INTERVENTION WERE OFFERED THIS TREATMENT. AFTER AN INITIAL BOWL DIARY, PATIENTS UNDERWENT LEAD PLACEMENT CONNECTED TO AN EXTERNAL STIMULATOR AND THOSE WHO RESPONDED AND AN IMPLANTED STIMULATOR PLACED. RESULTS WERE ASSESSED BY REPEATED DIARY. QOL SCORES AND CONTINENCE SCORES. OF 29 PATIENTS WHO HAD INITIAL PERCUTANEOUS STIMULATION, 27 SHOWED ADEQUATE IMPROVEMENT AND WENT ON TO PERMANENT IMPLANTED STIMULATOR. OF THESE, RESULTS WERE AVAILABLE ON 26. THE MEDIAN NUMBER OF FI EPISODES PER WEEK PREOPERATIVELY WAS 7.25. THE MEDIAN POST IMPLANTATION WAS ONE. FI EPISODES IMPROVED FOLLOWING SNM BY A MEAN OF 12.21 EPISODES PER WEEK (95% CONFIDENCE INTERVAL 4.91 TO 19.51, P VALUE-0.002). FOR THOSE WITH LONGER FOLLOW UP THE INITIAL IMPROVEMENT WAS SUSTAINED, THERE WAS A MEAN FOLLOW UP TIME OF 10.7 MONTHS. EARLY RESULTS ARE ENCOURAGING, WITH A SIGNIFICANT IMPROVEMENT IN FAECAL INCONTINENCE FOLLOWING SNM. THE RESULTS IN (B)(4) IN TERMS OF IMPROVEMENT IN SYMPTOM SEVERITY AND QUALITY OF LIFE ARE SIGNIFICANT AND COMPARABLE TO OTHER CENTRES. SNM OFFERS A GOOD ALTERNATIVE FOR PATIENT WITH END STATE FI. REPORTED EVENTS: ONE PATIENT WITH SACRAL NEUROMODULATION (SNM) FOR FECAL INCONTINENCE HAD THE PERMANENT STIMULATOR REMOVED FOLLOWING INFECTION AFTER ONE MONTH. THE PATIENT REPORTEDLY DECLINED REPLACEMENT. TWO PATIENTS WITH SNM FOR FECAL INCONTINENCE DEVELOPED INFECTION AFTER PERMANENT STIMULATOR PLACEMENT. THE PATIENTS WERE REPORTEDLY SUCCESSFULLY TREATED WITH INTRAVENOUS ANTIBIOTICS ALONE. TWO PATIENTS WITH SNM FOR FECAL INCONTINENCE HAD LEAD BREAKAGE REQUIRING LEAD REPLACEMENT. ONE PATIENT HAD THE STIMULATOR BATTERY FAIL REQUIRING THE STIMULATOR TO BE REPLACED. TWO PATIENTS WITH SNM FOR FECAL INCONTINENCE DEVELOPED INFECTIONS FOLLOWING THE TEMPORARY LEAD PLACEMENT. THE REPORTER STATED THAT THE LEAD WAS REMOVED AND THE PATIENTS WERE TREATED WITH INTRAVENOUS ANTIBIOTICS. THE PATIENTS THEN REPORTEDLY WENT FORWARD FOR THE SECOND STAGE IMPLANT. 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
    1656 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention