BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 916747 · Received September 20, 2007

    Report

    Report Number
    2182207-2007-03088
    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 INFO IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    SEE MFR REPORT 2182207-2007-03083. IT WAS REPORTED THROUGH LITERATURE THAT THE PATIENT HAD AN INFECTION OF THEIR INTERSTIM SYSTEM. VAN VOSKUILEN AC, ET AL. " A LONG TERM 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