BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWINSPEED MR 11X 1.5T

    MDR report key: 1168004 · Received September 19, 2008

    Report

    Report Number
    2183553-2008-00042
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    April 25, 2008
    Report Date
    July 2, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K013636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. GE CONTINUES TO ATTEMPT TO OBTAIN ADDITIONAL INFO REGARDING DETAILS OF THE EVENT INCLUDING SAR VALUES AND USE OF PT PADDING DURING SCAN.

    Description of Event or Problem · 1

    A PT REPORTEDLY RECEIVED ERYTHEMA AND BLISTERING OF THE SKIN AFTER AN MRI BREAST EXAM. ON DAY 1, THE PT WAS SCHEDULED FOR A CORE BIOPSY WITH MRI GUIDANCE. THE PROCEDURE WAS COMPLETED WITH NO APPARENT COMPLICATIONS AND PT COMPLAINTS. THE FOLLOWING PULSE SEQUENCES WERE USED AND START TIMES DOCUMENTED: AXIAL LOCALIZER (8:29), SAGGITAL LOCALIZER (8:30). T1 WEIGHTED SAGGITAL WITHOUT FAT SAT (8:33), 3 X T1 WEIGHTED SAGGITAL WITH FAT SAT-1 PRE CONTRAST + POST CONTRAST (8:36), T1 WEIGHTED AXIAL WITH FAT SAT (8:43). T1 WEIGHTED SAGGITAL WITH FAT SAT (8:53), T1 WEIGHTED AXIAL WITH FAT SAT (8:55), T1 WEIGHTED SAGGITAL WITH FAT SAT (9:02), T1 WEIGHTED AXIAL WITH FAT SAT (9:04). ON THE DAY 2, THE PT REPORTED REDNESS OF THE SKIN ON THE FAR LATERAL SIDE OF HER BREAST WHICH WAS AWAY FROM THE SITE OF THE BIOPSY. THE PT WENT TO THE EMERGENCY DEPT OF THE HOSP AND RECEIVED IV ANTIBIOTIC TREATMENT. ON DAY 3, THE PT WAS DISCHARGED AND SUSTAINED A LARGE AREA OF REDNESS AND BLISTERING OF THE SKIN. THE SITE PHYSICIAN INDICATED THAT THE PT RECEIVED A RF BURN BASED ON THE BIOPSY FINDINGS AND CLINICAL CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINSPEED MR 11X 1.5T LNH GE MEDICAL SYSTEMS, LLC 2294302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R