BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1032150 · Received April 21, 2008

    Report

    Report Number
    2182207-2008-02114
    Event Type
    Injury
    Date Received
    April 21, 2008
    Report Date
    March 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REF: WHITE ET AL. "SACRAL NERVE STIMULATION FOR TREATMENT OF REFRACTORY URINARY RETENTION: LONG-TERM EFFICACY AND DURABILITY." UROLOGY 2008;71(1):71-74. THE STUDY EXAMINED THE LONG-TERM EFFICACY AND DURABILITY OF SACRAL NERVE STIMULATION (SNS) FOR THE TREATMENT OF REFRACTORY, NON-OBSTRUCTIVE URINARY RETENTION. A RETROSPECTIVE STUDY OF 29 PTS WHO UNDERWENT SNS WITH THE INTERSTIM DEVICE FOR REFRACTORY, NON-OBSTRUCTIVE URINARY RETENTION WAS PERFORMED. THE MEAN FOLLOW-UP WAS 40 MONTHS. DEVICE COMPLICATIONS WERE NOTED. REPORTABLE EVENT: TWO PTS WHO REQUIRED INTERSTIM REVISION HAD IPG ASSOCIATED INFECTIONS.

    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 PROGRAMMER MODEL UNK| LEAD MODEL UNK