MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for EXABLATE 2100 manufactured by Insightec, Ltd.
[83949599]
The review of the device log files showed that the device performed according its specifications and no malfunctions occurred during the treatment. The patient's treatment log and the mr images were also thoroughly reviewed and no treatment anomalies that could be directly attributed to this event. During the treatment there were no user stopped sonication events. Since the device performed as intended and no anomalies were noted in the treatment file, we can only speculate as to the cause of this event. However, calculating the energy density (ed) on the bone and comparing to 5 references of uf cases (which did not end with any ae) showed no difference in the ed levels. In addition, based on our extensive experience with sacral bone sonication, patients report discomfort when such nerve is "excited" by the sonication that may be heating the bone. However, we would expect the same thing here; i. E. Patient would have reported some discomfort right away. Other medical conditions, such as reported conditions of tarlov cyst or myalgic encephalomyelitis may also affect the patient. It should be noted also that patient positioning may also exacerbate underlying conditions. The device risk management for the uterine fibroid application includes the risk associated with sacral bone (i. E. May induce nerve "stimulation" leading to sacral nerve leg pain, etc. ) and with heating bone in general. According to all the data collected from our treating sites, up to date, more than 13,000 uf patients were treated and the risk for neurological damage is 0. 08%. Note: date of this report is based on insightec's retrospective analysis of complaints
Patient Sequence No: 1, Text Type: N, H10
[83949600]
Site reported that post treatment, the patient was found to have leg weakness confirmed via physical evaluation post mrgfus treatment for fibroid. Approximately one month later ((b)(6) 2016) the patient reported of slight improvement although she still has weakness in the right leg and thigh plus and has pain present in her groin and upper thigh. She reported that she was attending physio therapy. On the (b)(6) 2016 she reported that she had seen a neurologist and there is potential obturator nerve damage. He prescribed rest, no physio no exercise, no walking etc. For 6 weeks and prescribed prednisolone (steroid) and pregabalin for nerve pain relief. On (b)(6) 2017 the treating physician indicated that the patient has had nerve conduction tests an is still symptomatic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2017-00001 |
| MDR Report Key | 6829278 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-28 |
| Date of Event | 2016-10-20 |
| Date Facility Aware | 2017-01-23 |
| Date Mfgr Received | 2017-01-23 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2017-08-29 |
| 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 | 0 |
| Brand Name | EXABLATE 2100 |
| Generic Name | MR-GUIDED FOCUSED ULTRASOUND |
| Product Code | POH |
| Date Received | 2017-08-29 |
| Model Number | 2100 |
| Operator | HEALTH PROFESSIONAL |
| 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 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Other; 3. Required No Informationntervention | 2017-08-29 |