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 2017-12-08 for EXABLATE NEURO 4000 TYPE 1 EXABLATE 4000 TYPE 1.0 manufactured by Insightec, Ltd..
[94260842]
The retrospective analysis of the treatment data logs (exablate treatment report) indicated that the device performed as intended within specifications. Further analysis of the treatment data logs shows that the lesion was located in the subthalamus zona incerta region which is outside of indicated region of treatment of et in the us. Furthermore, the patient's overall skull density ratio ("sdr") was 0. 35; this sdr is contraindicated for the treatment of et in the us using exablate neuro (overall sdr must be greater than 0. 45 (? 0. 05)). The last five sonications which were performed at a higher power due to lower sdr with three targets intentionally distributed over approximately 3mm inferiorly and 1. 5mm posteriorly of an area. In conclusion, this event has been attributed to the physician ablating larger target area extending very inferiorly which has a potential for cerebral edema at the ablation site in turn causing the reported symptoms post-treatment.
Patient Sequence No: 1, Text Type: N, H10
[94260843]
On (b)(6) 2016 a (b)(6) year old male patient was treated with exablate neuro for essential tremor targeting the subthalamus and subthalamus zona incerta region. Approximately 72 hours post-treatment, the patient reportedly experienced moderate arm and leg weakness and went to the local hospital where he was prescribed steroids. On (b)(6) 2016 it was reported that the patient was hospitalized for 3 days and an mri scan taken during this hospital stay showed edema in the area of treatment. According to reporting, patient returned to the hospital on (b)(6) 2016 complaining of progressive weakness and intermittent swelling of the right arm and leg and that the leg is cold and stiff with decreased mobility. It was communicated by the site clinical team that the steroid dosage was decreased during this visit. The patient reportedly returned to the hospital on (b)(6) 2016 complaining of headache, dysarthria, confusion, and blurred vision and was admitted for approximately eight days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2017-00006 |
| MDR Report Key | 7100410 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-08 |
| Date of Report | 2017-12-08 |
| Date of Event | 2016-09-24 |
| Date Facility Aware | 2016-09-26 |
| Report Date | 2016-09-25 |
| Date Reported to Mfgr | 2016-09-25 |
| Date Mfgr Received | 2016-09-26 |
| Date Added to Maude | 2017-12-08 |
| 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 | MR. ANDREW HARRELL |
| Manufacturer Street | 4851 LBJ FREEWAY SUITE 400 |
| Manufacturer City | DALLAS TX 75244 |
| Manufacturer Country | US |
| Manufacturer Postal | 75244 |
| Manufacturer Phone | 2146302000 |
| Manufacturer G1 | INSIGHTEC, INC. |
| 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 NEURO |
| Generic Name | MR-GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2017-12-08 |
| Model Number | 4000 TYPE 1 |
| Catalog Number | EXABLATE 4000 TYPE 1.0 |
| Operator | PHYSICIAN |
| 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 P.O. BOX 2039 TIRAT CARMEL, ISRAEL 31290 IS 31290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-12-08 |