BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 14317974 · Received May 7, 2022

    Report

    Report Number
    2182207-2022-00757
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    January 7, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INTERSTIM_INS, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS. LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    KOPCSAY, K. S., MARCZAK, T. D., JEPPSON, P. C., CAMERON, A. P., KHAVARI, R., TEFERA, E., GUTMAN, R. E. TREATMENT OF REFRACTORY OVERACTIVE BLADDER WITH ONABOTULINUMTOXINA VS PTNS: TROOP TRIAL. INT UROGYNECOL J. DOI: 2022.10.1007/S00192-021-05030-3. SUMMARY: WE HYPOTHESIZED THAT PATIENTS WITH REFRACTORY OVERACTIVE BLADDER (ROAB) HAVE SIMILAR IMPROVEMENT WITH PERCUTANEOUS TIBIAL NERVE STIMULATION (PTNS) AND ONABOTULINUMTOXINA (BTX). THIS MULTICENTER COHORT STUDY COMPARED BTX AND PTNS IN WOMEN WITH ROAB. BASELINE INFORMATION INCLUDED OVERACTIVE BLADDER QUESTIONNAIRE (OABQ) SHORT FORM, URINARY DISTRESS INVENTORY-6 (UDI-6), AND VOIDING DIARY. PRIMARY OUTCOME WAS CURE, DEFINED AS ¿VERY MUCH BETTER¿ OR ¿MUCH BETTER¿ ON THE PATIENT GLOBAL IMPRESSION OF IMPROVEMENT (PGII) AND A REDUCTION IN OABQ SYMPTOM SEVERITY SCALE (SSS) =10 AT 3 MONTHS AFTER TREATMENT. ASSUMING 80% POWER TO DETECT A TEN-POINT DIFFERENCE IN OABQ-SSS, 80 PARTICIPANTS WERE REQUIRED PER GROUP. A TOTAL OF 150 PATIENTS WERE ENROLLED; 97 COMPLETED 3 MONTHS OF THERAPY AND WERE INCLUDED. AT BASELINE, BTX PATIENTS HAD MORE DETRUSOR OVERACTIVITY (70% VS 40%, P = 0.025), URGENCY INCONTINENCE (UUI; OABQ-SSS#6 4 VS 3, P = 0.02, SSS 65 VS 56, P = 0.04), BUT SIMILAR HEALTH-RELATED QUALITY OF LIFE (HRQL 49 VS 54, P = 0.28), VOIDS (7 VS 8, P = 0.13), AND UUI EPISODES (2 VS 2, P = 1.0). AT 3 MONTHS, CURE RATES WERE SIMILAR: BTX 50% VS PTNS 44.2% (P = 0.56). BOTH GROUPS HAD IMPROVED SSS (-37 VS -29, P = 0.08) AND HRQL (31 VS 24, P = 0.14). PATIENTS RECEIVING BTX HAD A GREATER IMPROVEMENT IN URGENCY (OABQ-SSS#2¿3 VS -2; P = 0.02) AND UUI (OABQ-SSS#6¿2 VS -1; P = 0.02). NO CHARACTERISTICS WERE PREDICTIVE OF CURE. CONCLUSIONS BTX RESULTED IN SIGNIFICANTLY GREATER IMPROVEMENT IN URGENCY AND UUI THAN PTNS, BUT NO DIFFERENCE IN SUCCESS BASED ON PGII AND OABQ-SSS, WHICH MAY BE DUE TO A LACK OF POWER. REPORTED EVENTS: 1. 3 PATIENTS IN THE BTX GROUP HAD UTIS DURING THE STUDY PERIOD. 2. 2 PATIENTS HAD URINARY RETENTION REQUIRING CATHETERIZATION. SEE ATTACHED ARTICLE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478522 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other