MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-24 for EXABALTE 4000 SYS004000-AA manufactured by Insightec Ltd.
[142870928]
The system technical performance during treatment was thoroughly reviewed; no technical issues were found. No system malfunction occurred.
Patient Sequence No: 1, Text Type: N, H10
[142870929]
On november 27, 2018, insightec was notified, that on (b)(6) 2018, a patient with bilateral intention tremor, underwent exablate thalamotomy for essential tremor for tremor relief in dominant right hand. The treatment initially resulted in complete tremor relief and no side effects were observed by the clinical team on the day of treatment. At day 12 post treatment follow-up, the patient reported floppiness in her right arm. On (b)(6) (49 days post-treatment), team reported that patient is undergoing physical therapy to help with arm floppiness and imbalance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2018-00011 |
| MDR Report Key | 8543484 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-24 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2019-04-24 |
| 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 |
| Manufacturer City | TIRAT CARMEL, 39120 |
| Manufacturer Country | IS |
| Manufacturer Postal | 39120 |
| 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 | 2019-04-24 |
| 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, 39120 IS 39120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-04-24 |