MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-01 for BRAINLAB NOVALIS TX manufactured by Feidkirchen.
[1803262]
My daughter received radiosurgery -brainlab novalis- treatment on (b)(6) 2009. On (b)(6) 2009, my daughter became very ill with symptoms of endocrine failure. Her dr stated to her husband and myself that during radiosurgery, an a-typical event occurred, that the radio beam traveled beyond the treatment site, thus, this adverse event resulted in pituitary gland failure, and that she was going to die. My daughter's husband ordered the medical records because, the dr would never discuss the incident with us again. He recorded on my daughter's medical chart that she had end stage terminal cancer with hypothalmic distress. My daughter's medical records of the radiosurgery treatment states that during the radiosurgery, a power outage occurred. This power outage occurrence during her radiosurgery needs to be investigated by the (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018432 |
| MDR Report Key | 1917257 |
| Date Received | 2010-12-01 |
| Date of Report | 2010-12-01 |
| Date of Event | 2009-10-15 |
| Date Added to Maude | 2010-12-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAINLAB NOVALIS TX |
| Generic Name | NONE |
| Product Code | LHN |
| Date Received | 2010-12-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEIDKIRCHEN |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-01 |