MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-21 for 3-T SYSTEM manufactured by Siemen's Corporation.
[632580]
Patient sedated and sleeping. The diffusion sequence was a 12 direction dti applied at the end of the protocol. Shortly after, the diffusion gradients were applied, the child's arms and legs began to visibly twitch, followed shortly by arm movements. The sequence was aborted. The child was not awakened by the scan. No additional sedation was administered. After waiting approximately 30-45 seconds, a 3-direction, i. E. Dwi-one portion of the diffusion sequence was run. In this instance, no discernable involuntary movement was observed nor was the child awakened by the scan. Dates of use: one day in 2007. Diagnosis or reason for use: mri of brain. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002806 |
| MDR Report Key | 871347 |
| Date Received | 2007-06-21 |
| Date of Report | 2007-06-21 |
| Date of Event | 2007-06-15 |
| Date Added to Maude | 2007-07-10 |
| 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 | 3 |
| 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 | 3-T SYSTEM |
| Generic Name | MRI |
| Product Code | MRI |
| Date Received | 2007-06-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855366 |
| Manufacturer | SIEMEN'S CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-21 |