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 2018-09-06 for EXABALTE 4000 SYS004000-AA manufactured by Insightec Ltd.
[119374327]
The system technical performance during treatment was thoroughly reviewed; no technical issues were found. No system malfunction occurred. All sonication parameters were within the normal ranges with no exceptional usage.
Patient Sequence No: 1, Text Type: N, H10
[119374328]
The patient underwent exablate thalamotomy for essential tremor. Despite testing foot strength throughout treatment and not observing any weakness, the patient displayed an inversion of the right foot immediately post treatment. The physician decided to keep the patient overnight and have them see a physical therapist. The patient required ankle/foot orthotics and was discharged to a specialty nursing facility. The inversion was still present at one week post treatment. At this time, there is no additional information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00004 |
| MDR Report Key | 7850909 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2008-08-08 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2012-12-13 |
| Date Added to Maude | 2018-09-06 |
| 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 INBAL BEN-TZVI |
| Manufacturer Street | 5 NACHUM HETH STREET |
| Manufacturer City | TIRAT CARMEL, 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer G1 | INSIGHTEC, LTD, |
| Manufacturer Street | 5 NACHUM HETH STREET |
| 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 | 3 |
| Brand Name | EXABALTE 4000 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2018-09-06 |
| Model Number | 4000 |
| Catalog Number | SYS004000-AA |
| 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 TIRAT CARMEL, 2039 IS 2039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-06 |