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 SYS940352 manufactured by Insightec Ltd.
[142907312]
The system technical performance was reviewed; no technical issues were found. No system malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[142907313]
Patient was treated on (b)(6) 2018 for essential tremor (et). After the treatment the tremor was almost resolved, but the patient experienced weakness on right side of the body and ataxia on the right upper and lower limbs. One day after the treatment, mri showed lesion in the targeted place accompanied by perifocal hyperintensity. Patient started to take prednisolone and was hospitalized for rehabilitation. Patient was discharged from the hospital on (b)(6) 2018 when symptoms improved. On 1, 3 and 6 months follow up ((b)(6) 2018), the patient visited the site for follow-up. Tremor was suppressed, and the ataxia improved. On (b)(6) dr. (b)(6) informed that these symptoms are expected and known as written in study protocol. He has considered to keep observation and will check again at 1-year follow-up in (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2019-00001 |
| MDR Report Key | 8543907 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-20 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2019-02-18 |
| 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 | 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, 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 | SYS940352 |
| 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 |