BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3855877 · Received June 9, 2014

    Report

    Report Number
    3007566237-2014-01566
    Event Type
    Injury
    Date Received
    June 9, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FASSOV, J.L., LUNDBY, L., LAURBERG, S., BUNTZEN, S., KROGH, K. A RANDOMIZED, CONTROLLED, CROSSOVER STUDY OF SACRAL NERVE STIMULATION FOR IRRITABLE BOWEL SYNDROME. ANN. SURG. 2014. VOL 00, NUMBER 00, 1-6. DOI: 10.1097/SLA.0000000000000559. SUMMARY: TO INVESTIGATE WHETHER SACRAL NERVE STIMULATION REDUCES IRRITABLE BOWEL SYNDROME (IBS)-SPECIFIC SYMPTOMS BY A RANDOMIZED, CONTROLLED, CROSSOVER STUDY. IBS AFFECTS 3% TO 22% OF THE POPULATION WORLDWIDE, BUT MOST PATIENTS CONTINUE TO HAVE SYMPTOMS DESPITE TREATMENT. PATIENTS INCLUDED FROM OUR TERTIARY CENTER HAD DIARRHEA PREDOMINANT OR MIXED IBS, WITH A MINIMUM BASELINE IBS SYMPTOM S CORE (GASTROINTESTINAL SYNDROME RATING SCALE¿IBS QUESTIONNAIRE) OF 40 POINTS REDUCED BY A MINIMUM OF 30% DURING THE PERCUTANEOUS NERVE EVALUATION BEFORE PERMANENT IMPLANTATION. PATIENTS WERE RANDOMIZED (1:1) TO HAVE THE STIMULATOR ON OR OFF FOR 1 MONTH AND THEN THE OPPOSITE FOR ANOTHER MONTH. INVESTIGATORS AND PATIENTS WERE NOT INFORMED OF THE SETTING. IBS-SPECIFIC SYMPTOMS AND QUALITY OF LIFE WERE ASSESSED THROUGH BOWEL DIARIES AND VALIDATED QUESTIONNAIRES. PRIMARY ENDPOINT WAS THE IBS-SPECIFIC SYMPTOM SCORE. TWENTY-ONE PATIENTS WERE RANDOMIZED. TEN WERE ELIGIBLE FOR ANALYSIS IN EACH GROUP. IBS-SPECIFIC SYMPTOM SCORES WERE SIGNIFICANTLY REDUCED DURING STIMULATION: THE MEDIAN DIFFERENCE IN THE ON-OFF GROUP WAS 12 (RANGE, -22 TO 44) AND IN THE OFF-ON GROUP-17.5 (RANGE,-48 TO-1) (P=0.0009). IBS SPECIFIC QUALITY-OF-LIFE SCORES IMPROVED SIGNIFICANTLY DURING STIMULATION: THE MEDIAN DIFFERENCE IN THE ON-OFF GROUP WAS 16 (RANGE, -24 TO 69) AND IN THE OFF-ON GROUP -42.5 (RANGE, -77 TO 0) (P = 0.0003). AT 1-YEAR FOLLOW-UP, THE MEDIAN IBS-SPECIFIC SYMPTOM SCORE (25; RANGE, 13¿65) WAS SIGNIFICANTLY LOWER THAN THAT AT BASELINE (62; RANGE, 45¿80) (P = 0.0001). SACRAL NERVE STIMULATION SIGNIFICANTLY REDUCES SYMPTOMS AND IMPROVES QUALITY OF LIFE OF HIGHLY SELECTED PATIENTS WITH IBS. REPORTED EVENT: ONE PATIENT HAD AN ELECTIVE REVISION OF THE LEAD FOR SUSPECTED MIGRATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RE-OBTAINED THE SYMPTOMATIC EFFECT AFTERWARDS. IT WAS NOTED THAT THERE WAS NO DEVICE MALFUNCTION. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. . PLEASE NOTE THAT THIS EVENT WAS INITIALLY REPORTED IN MANUFACTURING REPORT # 3007566237-2014-00885. GOING FORWARD ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED IN THIS MANUFACTURING REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334530 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention