BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3173704 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10487
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3080, LOT# L51858, IMPLANTED: (B)(6) 1998, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BACK IN 2006, THE PATIENT HAD ONE OF HER LEADS COME LOOSE AND IT HAD TO BE FIXED. THE PATIENT ALSO REQUESTED COMPATIBILITY GUIDELINES FOR ULTRASOUND, MRI, AND TEMPERATURE CHANGE, AS THE PATIENT HAD ISSUES WITH HER OVARIES AND NEEDED TO HAVE A DIAGNOSTIC ULTRASOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EVERY ONCE AND A WHILE THE PATIENT GOT A LITTLE DISCOMFORT AND THE DEVICE WAS AGITATING THEM A LITTLE BIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274288 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention