MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-18 for EXABLATE 4000 SYS940200 manufactured by Insightec.
[187759162]
Retrospective analysis has not indicated any technical failures. Treatment parameters were in line with typical range. The system performance was found to be in spec and as expected. No new risk recognized.
Patient Sequence No: 1, Text Type: N, H10
[187759183]
Patient underwent brain treatment for essential tremor. The tremor symptoms were reported to be fully resolved. On the 8-day follow-up the patient reported unbalancing. On (b)(6) 2020 (ten days post treatment) , the site reported on patient improvement with persisting ataxia (unbalancing on the treated side) and possibly some dysarthria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2020-00006 |
| MDR Report Key | 9848227 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-06-29 |
| Date Added to Maude | 2020-03-18 |
| 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 | MS. MEITAL TRANK |
| Manufacturer Street | 5 NACHUM HETH |
| Manufacturer City | TIRAT CARMEL,, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC |
| Manufacturer Street | NACHUM HETH 5 |
| 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 | EXABLATE 4000 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2020-03-18 |
| Model Number | 4000 |
| Catalog Number | SYS940200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC |
| Manufacturer Address | NACHUM HETH 5 TIRAT CARMEL, ISRAEL 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-03-18 |