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 2017-12-07 for EXABLATE NEURO 4000 TYPE 1 manufactured by Insightec, Ltd..
[94154836]
The retrospective analysis of the treatment data showed that the device performed as intended. Due to the patient complaining of the headache during the treatment, the physician decided to extend the sonication time to up to 28sec, while reducing the power so that the exact amount energy required is unchanged. This approach likely caused a medial-lateral smearing and elongated superior-inferior heat spread. The event of "elongated" sonication thermal spots and the required mitigating steps to manage such events are already part of physician training material: using the exablate sw feature of the low power act temporal mask to manage the effect on spot shape; marking off the hyperostosis with nprs and tilting the traducer (pitch) to avoid this focal area would have potentially resulted in non-smeared tighter focal heat; it is highly recommended to use shorter sonication durations to mitigate a medial-lateral smearing and elongated superior-inferior heat spread. Insightec has discussed this analysis and the mitigating steps (as described above) with the treating physician. Further physician feedback on patient status indicated patient showed good signs of improvement and is satisfied with treatment outcomes. Insightec internal reference number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94154837]
On (b)(6) 2017, a (b)(6) female patient had an exablate mrgfus procedure to the left vim target for the treatment of essential tremor (et). It was reported that the patient repeatedly stopped sonications due to pain and at the end of the treatment experienced some nausea. Complete tremor relief was reported following the treatment. At the 11-day post-treatment follow up, it was reported that the patient experienced severe facial numbness and temperature sensitivity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2017-00005 |
| MDR Report Key | 7097194 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-06-13 |
| Date Facility Aware | 2017-06-26 |
| Report Date | 2017-06-26 |
| Date Reported to Mfgr | 2017-06-26 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-12-07 |
| 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 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 31290 |
| 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 | 2017-12-07 |
| Model Number | 4000 TYPE 1 |
| 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. Other | 2017-12-07 |