MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2011-06-14 for LEKSELL GAMMAPLAN NA manufactured by Elekta Instrument Ab.
[2722386]
In the prescription dose dialog, lgp displays a measure called "equivalent tmr classic prescription dose" (etcpd). According to the manual, the aim of providing tmr classic comparisons is "to find the dose prescription using convolution which gives approximately the same shot times and total beam-on time, given that the tmr classic dose algorithm provides the clinically proven dose prescription. " as explained in the manual, the etcpd is only a rough estimate based on a single point measurement. Also, it uses different output factors than the tmr classic algorithm in previous releases. The etcpd is also displayed when the user has selected the tmr10 algorithm. However analysis has shown that tmr10 dose prescriptions are in fact better approximations of original dose prescriptions obtained with lgk b/c/4c than the etcpd, so in this case the value of etcpd is not clear. As a consequence, there is a risk that the user may interpret the instructions in the manual too literally, and adjust the tmr10 dose description to obtain an etcpd that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
Patient Sequence No: 1, Text Type: D, B5
[9891749]
Investigation is on-going so follow-up reporting to this mdr will be provided to fda upon completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2011-00004 |
| MDR Report Key | 2581726 |
| Report Source | 00,07 |
| Date Received | 2011-06-14 |
| Date of Report | 2011-06-14 |
| Date of Event | 2011-05-17 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2012-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | KUNGSTENSGATAN 18 |
| Manufacturer City | STOCKHOLM |
| Manufacturer Country | SW |
| Manufacturer Phone | 293654250 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMAPLAN |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2011-06-14 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | KUNGSTENSGATAN 18 STOCKHOLM SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-14 |