MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-08 for EXABLATE 4000 SYS940200 manufactured by Insightec Ltd.
[141166221]
No technical issues were found. No system malfunction occured.
Patient Sequence No: 1, Text Type: N, H10
[141166222]
On (b)(6) 2019 insightec was made aware of customer complaint regarding event following brain treatment with exablat 4000 system. The patient underwent exablate thalamotomy for essential tremor treatment in (b)(6) on (b)(6) 2019. Immediately post treatment the patient presented ataxia and at 1-week follow-up (b)(6) complained about hemiparesis (side weakness), which was verified by neurological examination at the site. The site recommended on physiotherapy. According to the site ((b)(6) report, the patient suffered from weakness in the right hand and leg and needed physical therapy. On (b)(6), (b)(6) team updated that patient is improving, going without a walker and in overall good status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2019-00003 |
| MDR Report Key | 8490157 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-03-13 |
| Device Manufacturer Date | 2015-01-22 |
| Date Added to Maude | 2019-04-08 |
| 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 STREET |
| Manufacturer City | TIRAT CARMEL, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC LTD |
| Manufacturer Street | 5 NACHUM HETH |
| 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 | 2019-04-08 |
| Model Number | 4000 |
| Catalog Number | SYS940200 |
| 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 | 2019-04-08 |