BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGNA HISPEED LX

    MDR report key: 5206105 · Received November 5, 2015

    Report

    Report Number
    2183553-2015-00024
    Event Type
    Death
    Date Received
    November 5, 2015
    Date of Event
    September 18, 2015
    Report Date
    October 6, 2015
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K962061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INITIAL INFORMATION PROVIDED BY THE CUSTOMER, THE ROOT CAUSE APPEARS TO BE INAPPROPRIATE CLINICAL DECISION. THE LABELING CLEARLY STATES THAT PATIENTS WITH IMPLANTS ARE CONTRAINDICATED. A FAILURE TO FOLLOW THE PATIENT SCREENING PROCEDURES PROVIDED IN THE INSTRUCTIONS FOR USE AND NOT FOLLOWING THE MANUFACTURER'S RECOMMENDED CONDITIONS FOR USE COULD HAVE LED TO THIS ADVERSE EVENT. SYSTEM FILES WERE REVIEWED AND NO SYSTEMIC ISSUES WERE IDENTIFIED. THE SYSTEM APPEARS TO HAVE BEEN OPERATING WITHIN SPECIFICATIONS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER, WHO HAS NOT PROVIDED ADDITIONAL INFORMATION. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED AFTER MULTIPLE ATTEMPTS AS FOLLOWS: (B)(6) 2015 PHONE, (B)(6) 2015 PHONE, (B)(6) 2015 VOICE MESSAGE. REPORTER EMAIL ADDRESS NOT PROVIDED. DATE OF MANUFACTURER TO BE PROVIDED. THIS CORRESPONDS TO USER FACILITY REPORT#: (B)(4). GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE PAIN PUMP EXPERIENCED SUDDEN ABDOMINAL NUMBNESS SHORTLY FOLLOWING COMMENCEMENT OF A RIGHT KNEE MRI. THE PROCEDURE WAS IMMEDIATELY HALTED AND THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR EVALUATION. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735679 SIGNA HISPEED LX NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC MSF019

    Patients

    Seq Age Sex Outcome Treatment
    1 Death