BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1082488 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04392
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: HASSOUNA MM, ELKELINI MS. EARLY VERSUS LATE TREATMENT OF VOIDING DYSFUNCTION WITH PELVIC NEUROMODULATION. CAN UROL ASSOC. J. 2007;1(2): 106--110. WE EXAMINED PATIENT RESPONSE TO PELVIC NEUROMODULATION WHEN IT WAS APPLIED EARLY VERSUS LATE IN THE POST DIAGNOSIS OF VOIDING DYSFUNCTION. WE CONDUCTED A RETROSPECTIVE STUDY OF 42 PATIENTS (38 WOMEN AND 4 MEN) WITH VOIDING DYSFUNCTION WHO UNDERWENT SURGERY FOR IMPLANT OF INTERSTIM. REPORTABLE EVENT: IN THE EARLY GROUP, ONE PATIENT HAD POOR RESPONSE DUE TO A WOUND INFECTION.

    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 Other| R LEAD MODEL UNK N=1| EXTENSION MODEL 3095 N=1| PROGRAMMER MODEL UNK N=1