BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1069930 · Received July 7, 2008

    Report

    Report Number
    2182207-2008-03804
    Event Type
    Injury
    Date Received
    July 7, 2008
    Report Date
    June 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    JOURNAL REFERENCE: TJANDRA JJ, CHAN MK, YEH CH, MURRAY-GREEN C. SACRAL NERVE STIMULATIONS IS MORE EFFECTIVE THAN OPTIMAL MEDICAL THERAPY FOR SEVERE FECAL INCONTINENCE: A RANDOMIZED, CONTROLLED STUDY. DIS COLON RECTUM. 2008; 51(5): 494-502. THIS RANDOMIZED STUDY WAS DESIGNED TO COMPARE THE EFFECT OF SACRAL NEUROMODULATION WITH OPTIMAL MEDICAL THERAPY IN PATIENTS WITH SEVERE FECAL INCONTINENCE. FULL-STAGE SACRAL NERVE STIMULATION WAS PERFORMED IN 53 OF THESE 54 "SUCCESSFUL" PATIENTS. THERE WERE NO SEPTIC COMPLICATIONS. IN THE SACRAL NERVE STIMULATION GROUP, THERE WAS A SIGNIFICANT (P<0.0001) IMPROVEMENT IN FECAL INCONTINENCE QUALITY OF LIFE INDEX IN ALL FOUR DOMAINS. BY CONTRAST, THERE WAS NO SIGNIFICANT IMPROVEMENT IN FECAL CONTINENCE AND THE FECAL INCONTINENCE QUALITY OF LIFE SCORES IN THE CONTROL GROUP. REPORTABLE EVENT: ADVERSE EVENTS WITH SNS INCLUDED SEROMA WITH 1 PATIENT OR 2%, WHICH RESOLVED AFTER PERCUTANEOUS ASPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LEAD MODEL 3080 N=1| PROGRAMMER MODEL UNK N=1