BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPG GENERAL

    MDR report key: 1082564 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04384
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: KESSLER, T.M., ET AL., "SACRAL NEUROMODULATION FOR REFRACTORY LOWER URINARY TRACT DYSFUNCTION: RESULTS OF A NATIONWIDE REGISTRY IN FOREIGN COUNTRY" EUROPEAN UROLOGY, (2007) 51: 1357- 63. THE ARTICLE DISCUSSES THE TREATMENTS AND OUTCOMES OF 209 PATIENTS. ADVERSE EVENTS WERE RECORDED DURING THE INITIAL TEST PHASE AND/OR DURING OR FOLLOWING TRADITIONAL ONE-STAGE TECHNIQUE. REPORTABLE EVENT: DURING THE TEST PHASE ONE PT REPORTED PAIN AT THE LEAD SITE. SURGICAL INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

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