BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3203041 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11224
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 10, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V009140, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DOCTOR WAS REQUESTING COMPATIBILITY GUIDELINES FOR MRI WITH THE AREA TO BE SCANNED CONSISTING OF THE C-SPINE AND HIP. IT WAS NOTED THAT THE PATIENT HAD THE SYSTEM EXPLANTED THREE WEEKS AGO. IT WAS INDICATED THAT THERE WAS NO DEVICE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302013 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention