BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 933158 · Received October 25, 2007

    Report

    Report Number
    2182207-2007-03528
    Event Type
    Injury
    Date Received
    October 25, 2007
    Report Date
    October 26, 2007
    Manufacturer
    NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: HETZER, ET AL., QUALITY OF LIFE AND MORBIDITY AFTER PERMANENT SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE, ARCH SURG. JAN 2007; 142: 8-13. A PROSPECTIVE TRAIL TO ASSESS MORBIDITY AND QOL IN 44 PATIENTS TREATED WITH SNS. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REF: HETZER, ET AL., QUALITY OF LIFE AND MORBIDITY AFTER PERMANENT SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE, ARCH SURG, JAN 2007; 142: 8-13. A PROSPECTIVE TRAIL TO ASSESS MORBIDITY AND QOL IN 44 PATIENTS TREATED WITH SNS. THE ARTICLE DESCRIBES THE RESULTS OF A STUDY TO ASSESS THE QUALITY OF LIFE AND MORBIDITY OF LONG TERM SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE. A TOTAL OF 37 PATIENTS WERE IMPLANTED WITH A PERMANENT STIMULATOR. SHORT AND LONG TERM COMPLICATIONS ARE PRESENTED IN THE ARTICLE. THE ARTICLE LISTS INFO INDICATING A PATIENT EXPERIENCED A WOUND INFECTION AT THE STIMULATOR IMPLANT SITE 4 WEEKS POST-IMPLANT. TREATMENT INVOLVED REMOVAL OF THE STIMULATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R IMPLANTABLE LEAD| EXTENSION