BEUDAMED
    FDA Adverse Event Summary report: N

    INTERSTIM

    MDR report key: 921653 · Received September 21, 2007

    Report

    Report Number
    2182207-2007-03034
    Date Received
    September 21, 2007
    Report Date
    December 19, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: LATINI JM, ALIPOUR M, KREDER KJ. EFFICACY OF SACRAL NEUROMODULATION FOR SYMPTOMATIC TREATMENT OF REFRACTORY URINARY INCONTINENCE. UROLOGY. MAR 2006: 67(3): 550-3. THIS REPORT IS BEING FILED UNDER EXEMPTION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: LATINI JM, ALIPOUR M, KREDER KJ. EFFICACY OF SACRAL NEUROMODULATION FOR SYMPTOMATIC TREATMENT OF REFRACTORY URINARY URGE INCONTINENCE. UROLOGY, MAR 2006; 67(3): 550-3. THE ARTICLE DESCRIBES THE EXPERIENCE OF 41 PATIENTS BEING TREATED WITH SACRAL NERVE STIMULATION FOR A URGE INCONTINENCE. REPORTABLE EVENTS: IPG MODEL 3023 (N=9) - NINE PATIENTS EXPERIENCED INFECTIONS (6 SUPERFICIAL WOUND INFECTIONS, 2 CELLULITIS, 1 GRAM POSITIVE) IN THE AREA OF THE IPG IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R