BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1892700 · Received October 28, 2010

    Report

    Report Number
    3004209178-2010-08581
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LATE REPORTS: REASON FOR THE LATE MDR IS DUE TO THE IMPLEMENTATION OF A PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A COMPLAINT ABOUT THE STIMULATION SENSATION. WHILE THE STIMULATION WAS TURNED ON AT 7.8, PAIN AROUND THE URETHRAL AREA WAS FELT. WHEN THE STIMULATION WAS DECREASED TO 4.0 THE PAIN STOPPED. FOLLOWING THE IMPLANT TODAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention