MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-24 for EXABALTE 4000 SYS940350 manufactured by Insightec Ltd.
[142878085]
The system technical performance during treatment was thoroughly reviewed;no technical issues were found. No system malfunction occurred. All sonication parameters were within the normal ranges with no exceptional usage.
Patient Sequence No: 1, Text Type: N, H10
[142878086]
The patient underwent exablate thalamotomy for essential tremor and no side effects were recorded on the day of treatment. On (b)(6) 2018, insightec learned that after treatment the patient was a little unsteady on her feet, but she managed to walk from the mr room. After returning to the ward patient had difficulties in walking. The patient was hospitalized for 2 weeks, being treated with a reducing dose of dexamethasone for 3 days. The patient through this time remained unstable but was able to walk with aids (frame). On (b)(6) 2018, when the case was discussed with the site team, the patient continues to slowly improve and is receiving physiotherapy. At this time, there is no additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00006 |
| MDR Report Key | 8542913 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2017-12-11 |
| Date Added to Maude | 2019-04-24 |
| 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 IDAN COHEN |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAT CARMEL, 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer G1 | INSIGHTEC LTD |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAT CARMEL, 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABALTE 4000 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2019-04-24 |
| Model Number | 4000 |
| Catalog Number | SYS940350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC LTD |
| Manufacturer Address | 5 NACHUM HETH STREET TIRAT CARMEL, 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2019-04-24 |