BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3855757 · Received June 9, 2014

    Report

    Report Number
    3007566237-2014-01565
    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
    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, 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). IBSSPECIFIC 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 EXPERIENCED PERSISTENT POSTOPERATIVE PAIN AT THE IMPLANTATION SITE NECESSITATING RELOCATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S PAIN RESOLVED AFTER RELOCATION OF THE DEVICE. 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
    334649 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention