BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1032151 · Received April 21, 2008

    Report

    Report Number
    2182207-2008-02116
    Event Type
    Injury
    Date Received
    April 21, 2008
    Report Date
    April 2, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REF: GIGNOUX ET AL. "STUDY OF THE EFFICACY AND MEDIUM-TERM COMPLICATIONS OF 41 SACRAL NERVE NEUROSTIMULATORS (INTERSTIM, MEDTRONIC, U.S.A.) IN REFRACTORY URINARY DISORDERS." PROG UROL 2007;17(7):1355-1361. SINGLE-CENTER RETROSPECTIVE FOLLOW-UP STUDY, EFFICACY IN THE SHORT-AND MEDIUM-TERM, COMPLICATIONS AND REVISIONS, OF 41 PTS TREATED FOR URINARY DISORDERS WITH THE IMPLANTATION OF A SACRAL NERVE NEUROSTIMULATION INTERSTIM (TM). THE PTS WITH A MEAN AGE OF 54.6 WERE FOLLOWED FOR AN AVERAGE OF 20.5 MONTHS. REPORTABLE EVENT: COMPLICATIONS INCLUDED 1 INFECTION WHICH REQUIRED REMOVAL AT 1 MONTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER: MODEL UNK N=1| EXTENSION: MODEL UNK N=1| LEAD: MODEL UNK N=1