BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 7488887 · Received May 4, 2018

    Report

    Report Number
    3007566237-2018-01352
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    February 12, 2018
    Report Date
    July 16, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN; IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    AMUNDSEN, C. L, KOMESU, Y. M., CHERMANSKY, C., GREGORY, W. T. MYERS, D. L., HONEYCUTT, E. F., VASAVADA, S. P., NGUYEN, J. N. TWO-YEAR OUTCOMES OF SACRAL NEUROMODULATION VERSUS ONABOTULINUMTOXINA FOR REFRACTORY URGENCY URINARY INCONTINENCE: A RANDOMIZED TRIAL. EUROPEAN ASSOCIATION OF UROLOGY. 2018. DOI: 10.1016/J.EURURO.2018.02.011 SUMMARY: URGENCY URINARY INCONTINENCE (UUI) IS A CHRONIC CONDITION FOR WHICH SACRAL NEUROMODULATION (SNM) (INTERSTIM/MEDTRONIC) AND ONABOTULINUMTOXINA (BTX) (BOTOXA/ALLERGAN) ARE UTILIZED. THESE THERAPIES HAVE NOT BEEN COMPARED OVER EXTENDED TIME. OBJECTIVE: TO COMPARE UUI EPISODES (UUIE) OVER 24 MO FOLLOWING SNM OR BTX. DESIGN, SETTING, AND PARTICIPANTS: MULTICENTER, OPEN-LABEL, RANDOMIZED, EXTENSION TRIAL (FEBRUARY 2012¿JULY 2016) AT NINE US MEDICAL CENTERS INVOLVING 386 WOMEN WITH _6 UUIE OVER 3 D INADEQUATELY MANAGED BY MEDICATIONS. PARTICIPANTS WERE CLINICAL RESPONDERS TO TREATMENT: _50% REDUCTION IN UUIES AFTER SNM PLACEMENT OR 1 MO POST BTX. SNM (N = 194) VERSUS 200 U BTX (N = 192). SNM REPROGRAMMINGS OCCURRED THROUGHOUT THE 24 MO. AFTER 6 MO, TWO ADDITIONAL BTX INJECTIONS WERE ALLOWED. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PRIMARY OUTCOME: CHANGE IN MEAN DAILY UUIE OVER 24 MO. SECONDARY OUTCOMES: NO UUIE, _75% AND _50% UUIE REDUCTION; OVERACTIVE BLADDER QUESTIONNAIRE SHORT FORM; URINARY DISTRESS INVENTORY SHORT FORM; INCONTINENCE IMPACT QUESTIONNAIRE; PATIENT GLOBAL IMPRESSION OF IMPROVEMENT; OVER- ACTIVE BLADDER SATISFACTION OF TREATMENT QUESTIONNAIRE; AND ADVERSE EVENTS (AES). PRIMARY ANALYSIS USED A LINEAR MIXED MODEL. RESULTS AND LIMITATIONS: OUTCOME DATA WERE AVAILABLE FOR 26 0/298 (87%) CLINICAL RESPONDERS. NO DIFFERENCE IN DECREASED MEAN UUIE WAS FOUND OVER 24 MO (_3.88 VS _3.50 EPISODES/D,95% CONFIDENCE INTERVAL [CI] = _0.14¿0.89; P = 0.15), WITH NO DIFFERENCES IN UUI RESOLUTION, _75% OR _50% UUIE REDUCTION. BTX GROUP MAINTAINED HIGHER SATISFACTION (MEAN DIFFERENCE = _9.14, 95% CI = _14.38¿_3.90; P 0.001), TREATMENT ENDORSEMENT (MEAN DIFFERENCE = _12.16, 95% CI = _17.7¿_6.63; P 0.001) THROUGH 24 MO. OTHER SECONDARY MEASURES DID NOT DIFFER. RECURRENT URINARY TRACT INFECTIONS (UTIS) WERE HIGHER AFTER BTX (24% VS 10%; P 0.01), 6% REQUIRED INTERMITTENT CATHETERIZATION POST SECOND INJECTION. SNM REVISION AND REMOVALS OCCURRED IN 3% AND 9% PATIENTS, RESPECTIVELY. CONCLUSIONS: BOTH TREATMENTS OFFERED SUSTAINABLE UUI IMPROVEMENT, AND HIGHER BTX DOSING HAD LOW CLEAN INTERMITTENT CATHETERIZATION RATES, BUT WITH UTI RISK. SNM REVISION/REMOVAL RATES WERE LOW DUE TO STANDARDIZED LEAD PLACEMENT WITH STRICT TREATMENT RESPONSE DEFINITIONS. PATIENT SUMMARY: WE COMPARED A LARGE GROUP OF US WOMEN WITH SEVERE URGENCY URINARY INCONTINENCE (UUI) WHO RECEIVED SACRAL NEUROMODULATION (INTERSTIM) OR ONABOTULINUMTOX- INA (BOTOX A) THERAPY DURING A 2-YR PERIOD. WE FOUND THAT BOTH THERAPIES HAD SIMILAR SUCCESS IN REDUCING UUI SYMPTOMS, AND ADVERSE EVENTS WERE LOW. HOWEVER, WOMEN IN THE BOTOXA GROUP HAD HIGHER SATISFACTION AND ENDORSEMENT WITH THEIR TREATMENT, BUT WITH A HIGHER CHANCE OF A URINARY TRACT INFECTION. WE CONCLUDE THAT BOTH THERAPIES OFFER SUSTAINED REDUCTION IN DAILY INCONTINENCE OVER 2 YR. REPORTED EVENTS: DEVICE REVISIONS OCCURRED IN 4/139 (3%) BECAUSE OF DECREASED EFFICACY. FOUR PATIENTS EXPERIENCED AN INFECTION WHICH UNDERWENT A DEVICE REMOVAL. FOUR PATIENTS EXPERIENCED A DECREASE IN EFFICACY WHICH UNDERWENT A DEVICE REMOVAL. TWO PATIENTS EXPERIENCED PAIN AND HAD THEIR DEVICE EXPLANTED. ONE PARTICIPANT WAS RE-IMPLANTED AFTER A RESOLVED SURGICAL SITE INFECTION. TWENTY SEVEN PATIENTS EXPERIENCED A URINARY TRACT INFECTION 1 TO 6 MONTHS AFTER IMPLANT. TWENTY ONE PATIENTS EXPERIENCED A URINARY TRACT INFECTION 7 TO 12 MONTHS AFTER IMPLANT. FIFTEEN PATIENTS EXPERIENCED A URINARY TRACT INFECTION 13 TO 24 MONTHS AFTER IMPLANT. ELEVEN PATIENTS EXPERIENCED A FALL 1 TO 6 MONTHS AFTER IMPLANT. EIGHT PATIENTS EXPERIENCED A FALL 7 TO 12 MONTHS AFTER IMPLANT. FOURTEEN PATIENTS EXPERIENCED A FALL 13 TO 24 MONTHS AFTER IMPLANT. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329788 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R