BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2810311 · Received October 31, 2012

    Report

    Report Number
    3007566237-2012-02592
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    May 31, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    DUELUND-JAKOBSEN, J., DUDDING, T., BRADSHAW, E., BUNTZEN, S., LUNDBY, L., LAURBERG, S., VAIZEY, C. RANDOMIZED DOUBLE-BLIND CROSSOVER STUDY OF ALTERNATIVE STIMULATOR SETTINGS IN SACRAL NERVE STIMULATION FOR FAECAL INCONTINENCE. THE BRITISH JOURNAL OF SURGERY. 2012;99(10):1445-1452. DOI: 10.1002/BJS.8867. SUMMARY: THIS STUDY AIMED TO DETERMINE WHETHER ALTERNATIVE STIMULATOR SETTINGS FOR SACRAL NERVE STIMULATION WOULD INCREASE TREATMENT EFFICACY. PATIENTS WITH SUSTAINED LOSS OF EFFICACY WERE RECRUITED FROM TWO INTERNATIONAL SPECIALIST CENTRES. A NUMBER OF ALTERNATIVE STIMULATION PARAMETERS WERE TESTED USING A DOUBLE-BLIND RANDOMIZED CROSSOVER STUDY DESIGN. STIMULATION SETTINGS TESTED WERE PULSE FREQUENCIES OF 6-9 AND 31 HZ, AND PULSE WIDTHS OF 90 AND 330'S, COMPARED WITH ONE STANDARD SETTING OF 14 HZ/210'S. TREATMENT EFFICACY WAS EVALUATED USING A DISEASE-SPECIFIC QUALITY-OF-LIFE SCORE (FECAL INCONTINENCE QUALITY OF LIFE SCALE, FIQLS) AND A BOWEL HABIT DIARY COMPLETED BEFORE RANDOMIZATION, DURING THE STUDY PERIOD AND AFTER 3 MONTHS OF FOLLOW-UP WITH ONE PREFERRED SETTING. FIFTEEN PATIENTS WERE ANALYSED. WITH ONE PREFERRED SETTING, THREE OF FOUR SUBDOMAINS IN THE FIQLS IMPROVED SIGNIFICANTLY. THE MEAN(S.D.) TOTAL NUMBER OF INCONTINENCE EPISODES DROPPED FROM 11-7(10-8) TO 4-8(4-5) PER 3 WEEKS (P = 0-011) AND IMPROVEMENTS WERE MAINTAINED AFTER 3 MONTHS OF FOLLOW-UP. OPTIMAL PACEMAKER SETTINGS WERE INDIVIDUAL, BUT A TREND TOWARDS HIGHEST PATIENT SATISFACTION AND IMPROVED TREATMENT OUTCOME WAS EVIDENT FOR HIGH-FREQUENCY STIMULATION (31 HZ/210'S), WHICH WAS PREFERRED BY EIGHT OF THE 15 PATIENTS. PATIENTS EXPERIENCING LOSS OF EFFICACY CAN EXPERIENCE IMPROVEMENT IF ALTERNATIVE PACEMAKER SETTINGS ARE TESTED. HIGH-FREQUENCY STIMULATION (31 HZ/210'S) WAS PREFERRED BY MORE THAN HALF OF THE PATIENTS, AND IMPROVED TREATMENT OUTCOME WAS SUSTAINED AT 3 MONTHS. REPORTED EVENT: ONE PATIENT HAD LOWER BACK TRAUMA THAT RESULTED IN DISPLACEMENT OF THE PERMANENT LEAD. ADDITIONAL INFORMATION WAS R EQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1