FDA Adverse Event
Injury
Summary report: N
LEKSELL STEREOTACTIC SYSTEM
MDR report key: 1360645
·
Received April 13, 2009
Report
- Report Number
- 9612186-2009-00007
- Event Type
- Injury
- Date Received
- April 13, 2009
- Date of Event
- February 16, 2009
- Report Date
- March 13, 2009
- Manufacturer
- ELEKTA INSTRUMENT AB
- Product Code
- HAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING. REMEDIAL INTERVENTION AND PT CONDITION CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE USER FACILITY. MORE INFO WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. GE MEDICAL SYSTEMS REPORTED THIS EVENT AS MDR 2183553-2009-00016.
Description of Event or Problem · 1
A PT BEING SCANNED ON GE SIGNA MRI WITH A LEKSELL STEREOTACTIC SYSTEM FRAME REPORTEDLY RECEIVED A 2,5 CM BURN ON THEIR HEAD WHILE BEING SCANNED. THE PT DID RECEIVE MEDICAL TREATMENT FROM THE HOSPITAL; HOWEVER, THE TYPE OF MEDICAL TREATMENT RECEIVED IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEKSELL STEREOTACTIC SYSTEM | INSTRUMENT, STEREOTAXIC AND ACCESSORIES | HAW | ELEKTA INSTRUMENT AB | G | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |