FDA Adverse Event
Injury
Summary report: N
SYNERGY XVI
MDR report key: 1172090
·
Received September 23, 2008
Report
- Report Number
- 9617016-2008-00008
- Event Type
- Injury
- Date Received
- September 23, 2008
- Date of Event
- March 17, 2008
- Report Date
- September 17, 2008
- Manufacturer
- ELEKTA LTD.
- Product Code
- IYE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING IN THIS CASE. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE PROVIDED.
Description of Event or Problem · 1
CT SCANS THAT DO NOT BELONG TO THE PLAN MAY BE USED IN SYNERGY XVI TREATMENTS, AS LONG AS THEY HAVE BEEN ACQUIRED DURING THE SAME SESSION (I.E. A BREATH HOLD AND A NORMAL SCAN, OR ANY OF THE PHASES IN A RESPIRATORY CORRELATED CT SCAN). BECAUSE THE GEOMETRY CAN BE VERY DIFFERENT IN DIFFERENT BREATHING PHASES, THIS CAN LEAD TO MISALIGNMENT ERRORS. A PATIENT WAS MISALIGNED BY 2 CM FOR 11 OUT OF 15 FRACTIONS BECAUSE THE WRONG SCAN WAS IMPORTED INTO SYNERGY XVI, WHICH MEANS THAT THE TUMOR HAS BEEN UNDERDOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY XVI | ACCELERATOR, LINEAR, MEDICAL | IYE | ELEKTA LTD. | MRT 9951 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |