BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INTERSTIM

    MDR report key: 935286 · Received October 30, 2007

    Report

    Report Number
    2182207-2007-03602
    Event Type
    Injury
    Date Received
    October 30, 2007
    Report Date
    September 26, 2007
    Manufacturer
    NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: KENEFICK, NICHOLAS J., SACRAL NERVE NEUROMODULATION FOR THE TREATMENT OF LOWER BOWEL MOTILITY DISORDERS, THE ROYAL COLLEGE OF SURGEONS OF ENGLAND 2006; 88: 617-623. (SEE SCANNED PAGES)

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KENEFICK, NICHOLAS J., SACRAL NERVE NEUROMODULATION FOR THE TREATMENT OF LOWER BOWEL MOTILITY DISORDERS, THE ROYAL COLLEGE OF SURGEONS OF ENGLAND 2006; 88: 617-623. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE WHETHER SACRAL NERVE NEUROMODULATION CAN IMPROVE PATIENTS WITH DISORDERS OF BOWEL MOTILITY, WHEN CURRENT MAXIMAL TREATMENT HAS FAILED AND TO INVESTIGATE THE UNDERLYING PHYSIOLOGICAL MECHANISM OF ACTION. PATIENT COMPLICATIONS WERE REPORTED AS PART OF THE STUDY RESULTS. DURING PERCUTANEOUS SCREENING ONE PATIENT EXPERIENCED A SUPERFICIAL SKIN INFECTION REQUIRING THE REMOVAL OF THE TEMPORARY ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INTERSTIM EZW NEUROMODULATION 3057 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R EXTERNAL STIMULATOR