BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SACRAL STIMULATOR

    MDR report key: 1248121 · Received December 1, 2008

    Report

    Report Number
    2182207-2008-07864
    Event Type
    Injury
    Date Received
    December 1, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: VAN VOSKUILEN AC, WEIL EHJ, KERREBROECK PEVAV. TINED LEAD IMPLANTATION: RESULTS OF THE FIRST 37 IMPLANTS IN MAASTRICHT. NEUROMODULATION. NOVEMBER 20, 2004;8(3):182-193. PATIENTS WITH URGENCY-FREQUENCY (UF), URGE INCONTINENCE (UL), OR URINARY RETENTION (UR), WHO WERE REFRACTORY TO CONSERVATIVE THERAPY, UNDERWENT A STAGED TEST PROCEDURE USING THE NEW TINED LEAD. THIRTY PATIENTS WERE IMPLANTED, WITH FOLLOW-UP DATA AVAILABLE ON 28 PATIENTS. REPORTABLE EVENT: ONE PATIENT HAD A REVISION OF THE LEAD IN AN OPEN PROCEDURE DUE TO PARESTHESIA IN THE LEG, WHICH WAS STIMULATION DEPENDENT. SEE MFG REPORT # 2182207200807863.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3889 N=1| PROGRAMMER: MODEL UNK N=1