MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-05 for EXABLATE 4000 SYS940352 manufactured by Insightec Ltd.
[144114979]
The retrospective analysis has not indicated any technical failures or erroneous operation of the system. Edema of surrounding tissue with associated neurological deficits or symptoms is occasionally seen after tcmrgfus treatment and is described in the ifp and the study protocol as an anticipated risk; this edema usually causes transient and mild to moderate symptoms.
Patient Sequence No: 1, Text Type: N, H10
[144114980]
Patient (pt. No. (b)(6)) was treated on (b)(6) 2018 for essential tremor (et). This treatment is part of a clinical study, (b)(6). The patient complained on gait instability in left lower extremity. The patient needed extension of hospitalization and underwent rehabilitation from (b)(6). The patient was discharged from hospital on (b)(6) 2018, by foot with some weakness remained. According to the last follow up report, that occurred on (b)(6) 2018 the patient still complained of weakness of right leg and instability of the gait. Also slight left ataxia was present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2019-00004 |
| MDR Report Key | 8580836 |
| Date Received | 2019-05-05 |
| Date of Report | 2019-05-05 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2019-01-26 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2019-05-05 |
| 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 | 0 |
| Brand Name | EXABLATE 4000 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2019-05-05 |
| 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. Hospitalization; 2. Deathisabilit | 2019-05-05 |