BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2946055 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01365
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V922002, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT LOST MOVEMENT IN HER LEG 'ABOUT 10 DAYS.' IT WAS UNCLEAR IF THIS MEANT THE PATIENT HAD LOST MOVEMENT IN HER LEG FOR ABOUT 10 DAYS OR SHE LOST MOVEMENT IN HER LEG ABOUT 10 DAYS PRIOR TO THE REPORT. THE REPORTER STATED THAT IT HAD BEEN A 'GRADUAL PROGRESSION' STARTING WITH NOT BEING ABLE TO WALK WITHOUT A WALKER. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WANTED TO DO AN MRI SCAN OF THE PATIENT'S SPINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50728 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention