MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-08 for MINDMOTIONPRO MMPRO-EU manufactured by Mindmaze Sa.
[101888239]
This report is retrospectively filed with us fda based on the results of a quality audit, of mindmaze (b)(4). It was not known to the staff present (during the event) or the mindmaze representatives that the patient was on anti-epileptic medication. Patient was happy, alert and orientated on arrival. She has expressive aphasia but had communicated consent via her communication board to use the mmpro. After the session was commenced the patient started to demonstrate involuntary movements of her head and neck. Patient was asked if she was ok and happy to continue and she reported yes. However, the involuntary movements started to become more exaggerated and translated to her arm and trunk. Staff present were not familiar with the presentation of the patient so could not advise. Thus, medical staff were bleeped and observations of the patient were taken which were all normal. During this time the patient became tearful. The doctor who arrived was familiar with the patient and with her presentation, she expressed she was tearful and she was scared. He conducted a neurological assessment and reported that she had experienced an epileptic seizure and that her medication would be reviewed but reported her to be medically stable and well. The session was ceased and the patient was returned to her room by this time was once again calm and happy. The user manual for the mmpro device states, as a side effect, that "there is a small possibility of an epileptic seizure being provoked by photic stimulation. Should this occurs, stop using mindmotionpro immediately". This event was reported to the (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101888240]
During the training at the (b)(6), the first patient who tried the mindmotion pro experienced a mild seizure during the use of the device. Therapy was stopped immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013517146-2018-00001 |
| MDR Report Key | 7323802 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-08 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-07-03 |
| Date Mfgr Received | 2017-07-03 |
| Device Manufacturer Date | 2017-05-30 |
| Date Added to Maude | 2018-03-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SYLVAIN BOURRIQUET |
| Manufacturer Street | CHEMIN DE ROSENECK, 5 |
| Manufacturer City | LAUSANNE, 1006 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 1006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINDMOTIONPRO |
| Generic Name | SYSTEM, OPTICAL POSITION/MOVEMENT RECORDING |
| Product Code | LXJ |
| Date Received | 2018-03-08 |
| Catalog Number | MMPRO-EU |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINDMAZE SA |
| Manufacturer Address | CHEMIN DE ROSENECK 5 LAUSANNE, CH-1006 SZ CH-1006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-08 |