MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-28 for EXABLATE 4000 SYS940352 manufactured by Insightec Ltd.
[176760198]
The retrospective analysis has not indicated any technical failures or erroneous operation of the system. Treatment parameters were in line with typical range. The system performance was found to be according to spec and as expected. No new risk was recognized. On follow up mr images, lesion was seen in the targeted location, with extended hyperintensity (edema) in the surroundings which shrank over time.
Patient Sequence No: 1, Text Type: N, H10
[176760199]
A patient was treated for essential tremor as part of a clinical trial in (b)(6). On the evening of the treatment day, the patient presented slight numbness in the right-side lip and 1-3 fingers. At week 1 visit, the patient reported the numbness. Investigator suspected cheiro-oral syndrome due to "thalamic coagulation". At month 1 visit, the subject complained about hyperalgesia and abnormal perception of the right hand indicating thalamic pain. At 1 year visit (1 year and 3 months after the treatment date), these symptoms persist. The patient presented with complains characteristic of thalamic pain as the major cause of interference with daily activities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2020-00001 |
| MDR Report Key | 9637776 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2019-12-29 |
| Device Manufacturer Date | 2013-10-21 |
| Date Added to Maude | 2020-01-28 |
| 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 | 2020-01-28 |
| Model Number | 4000 |
| Catalog Number | SYS940352 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-28 |