LEKSELL GAMMA KNIFE MODEL 4C NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2012-04-26 for LEKSELL GAMMA KNIFE MODEL 4C NA manufactured by Elekta Instrument, Ab..

Event Text Entries

[2748145] There has been a discrepancy between the doses given in a variety of different treatment positions. This has not helped when the treatment was interrupted when the stereotactic frame had to be reapplied, after the pt had a fall during a bathroom break. Three sites received doses greater than originally planned. The delivered doses were reconstructed for review and it was established that these doses were well within clinical practice, and there is no reason for the pt to be concerned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9612186-2012-00001
• MDR Report Key: 2556511
• Report Source: 00,05,06
• Date Received: 2012-04-26
• Date of Report: 2012-03-08
• Date of Event: 2012-03-08
• Date Added to Maude: 2012-08-02
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 3
• Remedial Action: MA
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LEKSELL GAMMA KNIFE
• Generic Name: SYSTEM, RADIATION THERAPY, RADIONUCLIDE
• Product Code: IWB
• Date Received: 2012-04-26
• Model Number: MODEL 4C
• Catalog Number: NA
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ELEKTA INSTRUMENT, AB.
• Manufacturer Address: KUNGSTENSGATAN 18 STOCKHOLM SW

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-04-26