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 SYS940350 manufactured by Insightec Ltd.
[142880417]
The system technical performance during treatment was thoroughly reviewed; no technical issues were found. No system malfunction occurred. All sonication parameters were within the normal ranges with no exceptional usage.
Patient Sequence No: 1, Text Type: N, H10
[142880418]
The patient underwent exablate thalamotomy for essential tremor and no side effects were observed on the day of treatment. The patient reported the numbness to the site at there 1-month visit, on (b)(6) 2018, stating that the numbness began during treatment. At this point, the site was not certain whether the symptom was transient or permanent. At his 6 months visit, on (b)(6) 2018, the patient stated that his condition had not improved, and he still had significant numbness and pain in the right hand and arm; the pain report was not reported at 1-month. Insightec received the sae report on (b)(6) 2018. The patient has consulted with the site neurologist but is not receiving any sort of medication or treatment for the numbness. The patient is being treated with pain medication. At this time, there is no additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00005 |
| MDR Report Key | 8543350 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2013-12-17 |
| 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, IS 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer G1 | INSIGHTEC, LTD, |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAT CARMEL, IS 31290, |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31290, |
| 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 | SYS940350 |
| 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, 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-24 |