FDA Adverse Event
Injury
Summary report: N
MRI
MDR report key: 12691
·
Received April 12, 1994
Report
- Report Number
- MW1001549
- Event Type
- Injury
- Date Received
- April 12, 1994
- Date of Event
- July 30, 1993
- Report Date
- March 29, 1994
- Manufacturer
- PICKER INTL
- Product Code
- LNH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
TESTS HAVE SHOWN TWO MRI SESSIONS TRIGGERED ELECTRO-MAGNETIC FIELD HYPERSENSITIVITY (EMFH). RPTR FELT TINGLING DURING MRI'S, THEN INTENSE ALL-OVER LASTING PAIN LATER FOLLOWED BY SPASMS, INSOMNIA, HEADACHE, FATIGUE, MENTAL DEBILITY, INTESTINAL, AUDITORY, VISUAL, AND VOCAL PROBLEMS; SHE HAS EMFH STRESS, ALTERED AUTONOMIC NERVOUS SYSTEMS WHICH IMPAIRED IMMUNE SYSTEM, PRODUCING MANY ALLERGIES AND TOTAL STRESS OF ALL THIS RESULTED IN SEIZURES WITH TIME. SHE CAN NO LONGER USE ELECTRIC APPLIANCES, TOOLS OR EQUIPMENT SAFELY BECAUSE OF EMF RADIATION. RPTR HAS TO SELL PRESENT HOME AND MOVE TO RURAL AREA WITH LOW EMF. HAS TO GIVE UP HOBBIES AND STAY ON SPECIAL DIET AND AVOID ELECTRICITY. THIS HAS UPSET HER LIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRI | MRI MAGNETIC RESONANCE IMAGER | LNH | PICKER INTL | HPQ (VISTA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Not Applicable| L |