BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 2718004 · Received August 28, 2012

    Report

    Report Number
    3007566237-2012-02077
    Event Type
    Injury
    Date Received
    August 28, 2012
    Date of Event
    September 9, 2011
    Report Date
    July 31, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    LITERATURE: GILL, B. C., SWARTZ, M. A., RACKLEY, R. R., MOORE, C. K., GOLDMAN, H. B., VASAVADA, S. P. IMPROVEMENT OF BOWEL DYSFUNCTION WITH SACRAL NEUROMODULATION FOR REFRACTORY URGE URINARY INCONTINENCE. INTERNATIONAL UROGYNECOLOGY JOURNAL. 2012;23(6):735-741. DOI: 10.1007/S00192-011-1553-6. SUMMARY: SACRAL NERVE STIMULATION (SNS) IS APPROVED FOR UROLOGIC INDICATIONS IN THE USA AND, RECENTLY, FECAL INCONTINENCE. THIS STUDY DESCRIBED CONCOMITANT BOWEL DYSFUNCTION AND IMPROVEMENTS IN BOWEL AND URINARY SYMPTOMS AND QUALITY OF LIFE (QOL) IN WOMEN WITH REFRACTORY URGE URINARY INCONTINENCE (UUI) RECEIVING SNS. WOMEN (N=36) WITH REFRACTORY UUI RECEIVING SNS WERE PROSPECTIVELY ENROLLED. SURVEYS AND EXAMS WERE COMPLETED AT BASELINE AND FOLLOW-UP, WITH SYMPTOM AND QOL SCORES MEASURED USING VALIDATED SCALES (0-100, NONE-WORST). A TOTAL 24 WOMEN WERE FOLLOWED UP AT A MEDIAN OF 4.0 MONTHS POST-IMPLANTATION. OF THESE, 20 (83%) HAD BOWEL DYSFUNCTION, 13 (54%) USED BOWEL MEDICATIONS AT BASELINE, AND 11 (45%) CONTINUED THEM AFTER SNS. THE MEAN/MEDIAN URINARY (54.8 TO 32.6) AND BOWEL (23.4 TO 14.1) SYMPTOM SCORES IMPROVED SIGNIFICANTLY, AS DID URINARY (64.2 TO 14.3) BUT NOT BOWEL (2.4 TO 0.0) QOL SCORES. BOWEL DYSFUNCTION IS COMMON IN WOMEN WITH REFRACTORY UUI. SNS IMPROVES URINARY SYMPTOMS AND QOL, BUT IMPROVEMENT IN BOWEL SYMPTOMS DOES NOT TRANSLATE INTO SIGNIFICANT QOL CHANGES. REPORTED EVENT: 2 DEVICES WERE EXPLANTED DUE TO INFECTION. 1 PATIENT EXPERIENCED AN INFECTION DURING THE TRIAL PERIOD AND DID NOT GO ON TO PERMANENT IMPLANTATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention