BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 935284 · Received October 30, 2007

    Report

    Report Number
    2182207-2007-03603
    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

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KENEFICK, NICHOLAS J., SACRAL NERVE NEUROMODULATION FOR 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. PATIENTS (UNSPECIFIED NUMBER) EXPERIENCED MINOR LOCALIZED ELECTRIC SHOCKS WHEN PASSING THROUGH AMBIENT OR MAGNETIC FIELDS. DEACTIVATION OF THE PULSE GENERATOR MAGNET RENDERS THE IMPLANT LESS SENSITIVE AND ELIMINATED THIS PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IMPLANTABLE LEAD| LEAD EXTENSION