BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM SACRAL STIMULATOR

    MDR report key: 1242968 · Received November 21, 2008

    Report

    Report Number
    2182207-2008-07663
    Event Type
    Injury
    Date Received
    November 21, 2008
    Report Date
    November 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GURALNICK ML, BENOUNI S, O'CONNOR R C, EDMISTON C. CHARACTERISTICS OF INFECTIONS IN PATIENTS UNDERGOING STAGED IMPLANTATION FOR SACRAL NERVE STIMULATION. UROLOGY. 2007; 69(6): 1073-1076. TO REVIEW CLINICAL AND SURGICAL FACTORS IN PATIENTS WHO HAVE UNDERGONE STAGED SACRAL NERVE STIMULATOR IMPLANTATION AND TO DETERMINE WHETHER THERE ARE ANY IDENTIFIABLE RISK FACTORS FOR INFECTION. A RETROSPECTIVE CHART REVIEW WAS PERFORMED ON 76 CONSECUTIVE PATIENTS UNDERGOING STAGED IMPLANTATION FOR SACRAL NERVE STIMULATION FOR VOIDING DYSFUNCTION. REPORTABLE EVENT: IN 1 PATIENT AFTER STAGE 2 IPG PLACEMENT, THE PATIENT DEVELOPED INFECTION REQUIRING DEVICE REMOVAL THAT TWAS DEEMED IATROGENIC AFTER REPEATED PERCUTANEOUS DRAINAGES OF AN INITIALLY STERILE (CONFIRMED BY CULTURE), UNCOMFORTABLE WOUND SEROMA. SEE MFG REPORT # 2182207200807656.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION: MODEL UNK N=2| LEAD: MODEL UNK N=2| PROGRAMMER: MODEL UNK N=1