MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-24 for EXABALTE 4000 SYS940301 manufactured by Insightec Ltd.
[142876449]
The system technical performance was reviewed; no technical issues were found. No system malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[142876450]
On (b)(6) 2018, insightec was informed, by the site of (b)(6) hospital, that in several exablate neuro treatments for patients suffering from tremor, patients have experienced ataxia after the treatment. No other clinical information was shared, including not whether ataxia was transient or permanent, nor the time it was observed or diagnosed post treatment. The site later shared the dates of the 8 treatments in which ataxia was observed and were not reported to the company earlier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00014 |
| MDR Report Key | 8543340 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-24 |
| Date of Report | 2019-01-17 |
| Date Mfgr Received | 2018-12-19 |
| Device Manufacturer Date | 2013-10-21 |
| 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 | 0 |
| 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, 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 | SYS940301 |
| 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. Deathisabilit | 2019-04-24 |