BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 916742 · Received September 20, 2007

    Report

    Report Number
    2182207-2007-03083
    Event Type
    Injury
    Date Received
    September 20, 2007
    Report Date
    December 1, 2006
    Manufacturer
    NEUROLOGICAL DIVISION, MEDTRONIC, INC.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. IF FURTHER INFORMATION IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT. PLEASE SEE SCANNED PAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH LITERATURE THAT THE PATIENT HAD AN INFECTION OF THEIR INTERSTIM SYSTEM. THE DEVICE WAS EXPLANTED. VAN VOSKUILEN AC, ET AL. "A LONG TERM RESULTS OF NEUROMODULATION BY SACRAL NERVE STIMULATION FOR LOWER URINARY TRACT SYMPTOMS: A RETROSPECTIVE SINGLE CENTER STUDY." EUROPEAN UROLOGY. (SWITZERLAND) FEB 2006; 49(2):366-72.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW NEUROLOGICAL DIVISION, MEDTRONIC, INC. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other