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 SYS942000 manufactured by Insightec Ltd.
[142878255]
The system technical performance during treatment was thoroughly reviewed; no technical issues were found. No system malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[142878256]
On (b)(6) 2018, insightec was notified, that patient who was treated on (b)(6) 2018, reported of developing an ataxia in the right side in the upper and lower limbs, as well as dysarthria following treatment for essential tremor. The patient initially had a fall to the right side and was kept in the hospital for treatment. Motor functions were without deficit and tactile sensation also without a deficit. The patient was treated with dexametasone (8mgs/8 hours over 4-5 days) with a good response. As the patient's status improved, dexametasone was reduced (to 4 mgs/ 8 hours). On (b)(6) 2018 the se was considered as resolved and the patient was discharged with mild instability (uses a walker). On (b)(6) 2018, the patient came to one month visit and was assessed by neurologist. The patient maintains a minor ataxia with a lower limb predominance, using a crutch to walk and prefers to walk with another person close to him. Tremor relief remains stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00010 |
| MDR Report Key | 8543333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2018-03-14 |
| 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 TIRAT CARMEL |
| Manufacturer City | 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC LTD |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAT CARMEL, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 39120 |
| 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 | SYS942000 |
| 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, 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2019-04-24 |