MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-10 for EXABLATE 4000 manufactured by Insightec, Ltd..
[89189822]
The retrospective analysis of the treatment has not indicated any system technical failures or user error. The exablate neuro functioned as intended. Swelling of surrounding tissue with associated neurological deficits or symptoms has been reported after treatment with exablate neuro; such events have been transient in nature. The risk is inherent to the procedure. Approximately 2 weeks after the treatment, the treating physician reported that the patient is doing better and was released home. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89189823]
The patient was treated for the essential tremor with exablate neuro at (b)(6) hospital ((b)(6)). One day after the treatment, the physician reported that the patient experienced weakness of right upper extremity, the right side of the patient's mouth appeared to be bent downward and the patient was slurring his speech. The mr scans taken the morning after the treatment showed edema beyond the treatment spot. The patient remained in the hospital. Approximately 2 weeks after the treatment the treating physician reported that the patient is doing better and was released home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2017-00004 |
| MDR Report Key | 6938708 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-10 |
| Date of Report | 2017-10-10 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-10-10 |
| 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 P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| Manufacturer G1 | INSIGHTEC, LTD |
| Manufacturer Street | 5 NACHUM HETH STREET P.O. BOX 2039 |
| Manufacturer City | TIRAT CARMEL, ISRAEL 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 | 2017-10-10 |
| Model Number | EXABLATE 4000 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET P.O. BOX 2039 TIRAT CARMEL, ISRAEL 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-10-10 |