BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPG GENERAL

    MDR report key: 1071307 · Received July 8, 2008

    Report

    Report Number
    2182207-2008-03841
    Event Type
    Injury
    Date Received
    July 8, 2008
    Report Date
    June 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: JARRETT MED, DUDDING TC, NICHOLLS RJ, VAIZEY CJ, COHEN CRG, KAMM MA. SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE RELATED TO OBSTETRIC ANAL SPHINCTER DAMAGE. DIS COLON RECTUM. 2008; 51(5): 531-537. SPHINCTER REPAIR IS THE STANDARD TREATMENT FOR FECAL INCONTINENCE SECONDARY TO OBSTETRIC EXTERNAL ANAL SPHINCTER DAMAGE; HOWEVER, THE RESULTS OF THIS TREATMENT DETERIORATE OVER TIME. SACRAL NERVE STIMULATION HAS BECOME AN ESTABLISHED THERAPY FOR FECAL INCONTINENCE IN PTS WITH INTACT SPHINCTER MUSCLES. THIS STUDY INVESTIGATED IS EFFICACY AS A TREATMENT FOR 8 PTS WITH OBSTERTRIC-RELATED INCONTINENCE. REPORTABLE EVENT: THE STIMULATING DEVICE IN ONE PT CAME OUT OF THE WOUND EIGHT DAYS AFTER PLACEMENT. THE WOUND WAS NOT INFECTED; RATHER, THE DEVICE HAD TURNED THROUGH 90 DEGREES SO THAT IT WAS EDGE ON TO THE WOUND, PROBABLY AS A RESULT OF THE BUTTOCK POCKET BEING TOO SMALL. THE WOUND AND IMPLANT WERE WASHED AND THE POCKET WAS ENLARGED. THIS SAME PT CONTINUED TO GET PAIN FROM THE IMPLANT SITE AND NO IMPROVEMENT IN SYMPTOMS WITH STIMULATION. IN ADDITION THE PT REQUIRED PSYCHIATRIC TREATMENT FOR PROFOUND ANXIETY RELATED TO HAVING AN IMPLANT THAT WAS NOT BENEFITING HER AND INDEED WAS PAINFUL, AND THEREFORE HER IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPG GENERAL EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3093 N=1| PROGRAMMER MODEL UNK N=1