BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 6440021 · Received March 28, 2017

    Report

    Report Number
    3007566237-2017-01168
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    March 16, 2016
    Report Date
    March 28, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HOLD NG. 3/29/17. ABELSON, J. S., SPIEGEL, J. D., YEO, H. L., MAO, J., SUN, T. SEDRAKYAN, A., MILSOM, J. W., GARRETT, K. A. EVALUATION OF TRENDS IN THE USE OF INTERSTIM FOR FECAL INCONTINENCE: THE NEW YORK STATE EXPERIENCE. SURGICAL INNOVATION. SUMMARY: FECAL INCONTINENCE (FI) REPRESENTS A LARGE SOURCE OF MORBIDITY AND IS A CHALLENGING CLINICAL PROBLEM TO MANAGE. INTERSTIM WAS APPROVED TO TREAT FI IN 2011. LITTLE IS KNOWN ABOUT ITS ADOPTION. WE SOUGHT TO CHARACTERIZE PATTERNS OF USE OF INTERSTIM SINCE FOOD AND DRUG ADMINISTRATION APPROVAL FOR FI. THE (B)(6) DATABASE WAS USED TO EVALUATE INTERSTIM USE FOR FI FROM 2011 TO 2014. THE PRIMARY ENDPOINT WAS THE NUMBER OF SUCCESSFUL IMPLANTATIONS OF INTERSTIM. SECONDARY ENDPOINTS INCLUDED DEVICE REMOVAL, MEDIAN TIME TO REMOVAL OF DEVICE, 90-DAY INFECTION RATES, AND PERCENTAGE OF PROCEDURES PERFORMED BY SURGEON SPECIALTY AND GEOGRAPHIC LOCATION. RESULTS: A TOTAL OF 369 PATIENTS WITH FI UNDERWENT ¿STAGE 1¿ OF INTERSTIM FROM 2011 TO 2014. A TOTAL OF 302 PATIENTS UNDERWENT ¿STAGE 2,¿ YIELDING A TRIAL PERIOD FAILURE RATE OF 18.2%. THE MAJORITY OF PATIENTS WHO UNDERWENT SUCCESSFUL IMPLANTATION WERE FEMALE (87.7%) AND WHITE (78.8%). TWENTY-NINE PATIENTS UNDERWENT DEVICE REMOVAL AFTER A MEDIAN DURATION OF 147 DAYS. ESTIMATED RISK OF REMOVAL AT MEDIAN FOLLOW-UP OF 2 YEARS WAS 11.8%. COLORECTAL SURGEONS COMPRISED 51.1% OF ALL PROVIDERS FOLLOWED BY GYNECOLOGIC ( 24.4%) AND UROLOGIC SURGEONS (17.8%). A TOTAL OF 71.7% OF PROVIDERS PERFORMED <(><<)>5 PROCEDURES, WHILE 3 OF THE HIGHEST VOLUME PROVIDERS PERFORMED 50.7% OF ALL PROCEDURES. INTERSTIM FOR FI HAS BEEN USED BY A WIDE VARIETY OF PROVIDERS IN NEW YORK STATE ALTHOUGH ONLY A FEW HIGH-VOLUME PROVIDERS HAVE PERFORMED THE MAJORITY OF PROCEDURES. WHITE, FEMALE PATIENTS WITH MEDICARE ARE THE MOST COMMON RECIPIENTS OF INTERSTIM. FURTHER WORK MUST BE DONE TO DEVELOP STRATEGIES FOR IMPROVING ACCESS TO THIS TECHNOLOGY AND TO DETERMINE WHETHER VOLUME RELATES TO OUTCOMES. REPORTED EVENT: AN UNKNOWN NUMBER OF PATIENTS IMPLANTED FOR FECAL INCONTINENCE EXPERIENCED SPECIFIC ETIOLOGIES FOR DEVICE REMOVAL THAT WERE UNKNOWN HOWEVER ¿THEY ARE LIKELY¿ COMPARABLE TO FINDINGS FROM OTHER TRIALS AND INCLUDE PAIN AT INSERTION SITE, DETERIORATION OF BOWEL SYMPTOMS AND INFECTION. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222705 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R