BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1000106 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00779
    Event Type
    Injury
    Date Received
    February 19, 2008
    Report Date
    February 2, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REF: ABOSEIF ET AL. "SACRAL NEUROMODULATION: COST CONSIDERATION AND CLINICAL BENEFIT." JOURNAL OF UROLOGY. 2007; 70:1069-1074. THE PURPOSE OF THE STUDY WAS TO DEMONSTRATE THE EFFICACY OF SACRAL NEUROMODULATION AND COMPARE VOIDING-RELATED HEALTH CARE UTILIZATION COSTS BEFORE AND AFTER RECEIVING AN INTERSTIM IMPLANT. A RETROSPECTIVE REVIEW OF 65 PTS RECEIVING INTERSTIM THERAPY WAS COMPLETED. HEALTH CARE UTILIZATION WAS DETERMINED FOR THE YR BEFORE AND THE YR AFTER IMPLANTATION, AND INCLUDED HOSP AND CLINIC VISITS, DIAGNOSTIC AND THERAPEUTIC PROCEDURES, AND PRESCRIPTIONS. THE AUTHORS CONCLUDED THAT AFTER INTERSTIM THERAPY, VOIDING-RELATED HEALTH CARE COSTS ARE REDUCED. REPORTABLE EVENT: TWO PTS EXPERIENCED A WOUND-RELATED COMPLICATION AFTER IMPLANT: SUPERFICIAL WOUND INFECTION. THESE WERE MANAGED CONSERVATIVELY WITH ANTIBIOTICS, LOCAL WOUND CARE, AND PAIN CONTROL AS INDICATED WITHOUT ANY SEQUELAE.

    Devices

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

    Patients

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