BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3790079 · Received May 5, 2014

    Report

    Report Number
    3007566237-2014-01233
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_LABEL_ACC, SERIAL# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE STATED THE DIRECTOR OF AN MRI FACILITY IS STATING THAT A WOMAN COME IN WITH A FULL BODY SURESCAN SYSTEM ¿THE OTHER DAY¿ AND THEY WERE UNDER THE UNDERSTANDING THAT THERE WERE NO LIMITATIONS FOR RF COILS. IT WAS REPORTED EVERYTHING WAS FINE WITH THE PATIENT BUT STATES THEY PRINTED OFF AND COPIED A PIECE OF MARKETING MATERIAL SHOWING THERE NO ARE RF RESTRICTIONS. IT WAS NOTED THE NAME OF THE DOCUMENT WAS UNKNOWN AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268704 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97714

    Patients

    Seq Age Sex Outcome Treatment
    1