BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2537639 · Received April 17, 2012

    Report

    Report Number
    3007566237-2012-00782
    Event Type
    Injury
    Date Received
    April 17, 2012
    Date of Event
    November 1, 2010
    Report Date
    April 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, SERIAL#, IMPLANTED:, EXPLANTED:, PRODUCT TYP LEAD PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN, SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4). 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.

    Description of Event or Problem · 1

    LITERATURE: SACRAL NEUROMODULATOR INTERSTIM SURGICAL SITE INFECTION: TWO CASE REPORTS AZIN SHAHRYARINEJAD, MD, MPH,* MICHAEL D. VARDY, MD,* GILAD FILMAR, MD, MARY ELLEN WALTER, RN, MPA, COHN-S, CIC, AND JEFFREY KOCHER, MD. FEMALE PELVIC MED RECONSTR SURG 2010;16: 362Y364. DOI: 10.1097/SPV.0B013E3181F5ABE2 ABSTRACT: OBJECTIVE: THE SURGICAL SITE INFECTION RATE OF SACRAL NEUROMODULATOR PLACEMENT FOR THE TREATMENT OF REFRACTORY URGE URINARY INCONTINENCE IS REPORTED TO BE BETWEEN 5% AND 7.9%. OUR OBJECTIVE WAS TO REPORT THE INVESTIGATION PROCESS OF THESE INFECTIONS AND A POSSIBLE SOURCE FOR THEIR OCCURRENCE. METHODS: WE PERFORMED INFECTION CONTROL SURVEILLANCE OF TWO PATIENTS THAT UNDERWENT SACRAL NEUROMODULATOR PLACEMENT ON THE SAME DATE, IN THE SAME OPERATING ROOM, AND BY THE SAME STAFF WHO DEVELOPED SIMILAR SACRAL CELLULITIS POSTOPERATIVELY. RESULTS: THE INVESTIGATION REVEALED (B)(6) IN BOTH PATIENTS. NASAL CULTURES OF ALL PERSONNEL INVOLVED IN THEIR CARE, SHOWED (B)(6) WITH THE SAME ANTIBIOGRAM ONLY IN A MEDTRONIC REPRESENTATIVE WHO HAD MANIPULATED THE INTERSTIM SETTINGS. GENETIC ANALYSIS SHOWED THIS TO BE AN IDENTICAL STRAIN IN ONE PATIENT INFECTION. CONCLUSIONS: THE POSTOPERATIVE MANIPULATION OF DEVICE SETTINGS MAY BE A SOURCE OF SURGICAL SITE INFECTION, AND INFECTION CONTROL PRACTICES INCLUDING STRICT HAND WASHING, GLOVES, GOWN AND MASK MAY BE WARRANTED. KEY WORDS: INFECTION CONTROL SURVEILLANCE, INTERSTIM, SURGICAL SITE INFECTION, URINARY INCONTINENCE (FEMALE PELVIC MED RECONSTR SURG 2010;16: 362Y364). SACRAL NEUROMODULATOR PLACEMENT FOR THE TREATMENT OF REFRACTORY URGE URINARY INCONTINENCE (UUI) CONSISTS OF TWO STEPS. IN THE FIRST, A TINED LEAD IS PERCUTANEOUSLY PLACED TO THE S3 FORAMEN. CORRECT PLACEMENT IS VERIFIED BY THE APPROPRIATE MOTOR AND SENSORY RESPONSE AND BY RADIOGRAPHY. THE LEAD IS THEN CONNECTED TO AN EXTERNAL DEVICE FOR A TESTING PERIOD OF 3Y7 DAYS. THIS PROCEDURE IS GENERALLY PERFORMED IN AN OUTPATIENT SETTING UNDER LOCAL ANESTHESIA. AFTER A SUCCESSFUL TEST STIMULATION PERIOD, AN INTERNAL PULSE GENERATOR MAY BE PERMANENTLY IMPLANTED, TYPICALLY IN A POCKET IN THE UPPER BUTTOCK. THIS STEP IS PERFORMED UNDER GENERAL ANESTHESIA IN THE OPERATING ROOM. BOTH STEPS ARE DONE UNDER STERILE CONDITIONS. 1 VARIATION OF THIS TECHNIQUE IS THE TWO-STAGE IMPLANT. IN STAGE I AN ELECTRODE IS IMPLANTED, TUNNELED SUBCUTANEOUSLY, BROUGHT THROUGH THE SKIN AND CONNECTED TO A TEMPORARY NEUROSTIMULATOR. AFTER A SUCCESSFUL TRIAL, STAGE II IS PERFORMED WHERE A PERMANENT INTERNAL PULSE GENERATOR IS IMPLANTED. THE MAIN ADVANTAGE OF THIS VARIATION IS THE LACK OF LEAD MIGRATION AND PERHAPS BETTER STIMULATION.1 BOTH STAGES ARE DONE IN THE OPERATING ROOM UNDER STERILE CONDITIONS. LEAD SETTING AND MANIPULATION IS PERFORMED BY A MEDTRONIC REPRESENTATIVE, POSTOPERATIVELY. LITTLE HAS BEEN REPORTED IN THE LITERATURE REGARDING INFECTIOUS COMPLICATIONS; THE MAJOR STUDIES REPORTED THE INFECTION RATE BETWEEN 5% AND 7.9%.2,3 OUR OBJECTIVE WAS TO PERFORM AN INFECTION CONTROL INVESTIGATION OF TWO SURGICAL SITE INFECTIONS THAT OCCURRED IN OUR INSTITUTION, AND FIND A POSSIBLE SOURCE FOR THEIR OCCURRENCE. REPORTED EVENT: CASE 2 THE SECOND PATIENT WAS AN (B)(6) POSTMENOPAUSAL FEMALE WITH A MEDICAL HISTORY SIGNIFICANT FOR HYPERTENSION AND HYPOTHYROIDISM. SHE WAS AN INDEPENDENT, AMBULATORY AND SELF SUFFICIENT PATIENT LIVING AT HOME. SHE DENIED FECAL OR STRESS INCONTINENCE SYMPTOMS AND HAD FAILED SIX MONTHS OF MULTIPLE MEDICAL REGIMENS FOR UUI. SHE UNDERWENT A TWO-STAGED SACRAL NEUROMODULATOR PLACEMENT, WITH SUCCESSFUL CONTROL OF HER SYMPTOMS IN THE FOLLOWING 2 YEARS. SUBSEQUENTLY SHE COMPLAINED OF A SUDDEN INCREASE IN URGE SYMPTOMS, NO LEAD MIGRATION WAS DEMONSTRATED RADIOGRAPHICALLY BUT WAS SUSPECTED BECAUSE OF THE SUDDEN USE OF THE HIGHEST SETTINGS AND BATTERY FAILURE. THE PATIENT UNDERWENT, UNDER STERILE CONDITIONS A SECOND SURGERY WITH BATTERY REPLACEMENT, LEAD TESTING AND REPLACEMENT ON THE CONTRALATERAL SIDE. SETTING ADJUSTMENTS WERE MADE BY A MEDTRONIC REPRESENTATIVE POSTOPERATIVELY. ON POST-OPERATIVE DAY (POD) 7 THE PATIENT MISSED HER ROUTINE FOLLOW-UP VISIT. FOLLOW-UP VISIT ON POD 22 REVEALED SACRAL CELLULITIS. BLOOD AND WOUND CULTURES WERE TAKEN. THE PATIENT UNDERWENT DEVICE REMOVAL, SURGICAL DEBRIDEMENT AND TWO WEEKS OF INPATIENT INTRAVENOUS ANTIBIOTICS. SHE RECOVERED WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention