MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-04 for GAMMA KNIFE manufactured by .
[16041819]
Following a 45 minute long gamma knife procedure, i experienced the following problems. Sharp pains deep within my skull that lasted for a few seconds at a time, which was excruciating and debilitating. I had not expected any adverse effects and was told this has never happened before. My doctor confirmed that my symptoms were related to the procedure. So i'm sharing this to document that adverse effects do sometimes happen. Dates of use: 45 minute procedure. Diagnosis or reason for use: recurrence of schwannoma. Event abated after use: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018485 |
| MDR Report Key | 1917772 |
| Date Received | 2010-12-04 |
| Date of Report | 2010-12-04 |
| Date of Event | 2010-09-20 |
| Date Added to Maude | 2010-12-16 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 |
| Generic Name | GAMMA KNIFE |
| Product Code | IWB |
| Date Received | 2010-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-04 |