MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-04 for EXABLATE 4000 SYS940300 manufactured by Insightec Ltd.
[181916455]
The information on the article couldn't be confirmed since the site refused to cooperate. No ability to investigate.
Patient Sequence No: 1, Text Type: N, H10
[181916456]
This complaint was known to insightec via published article (dystonia following thalamic neurosurgery: a single centre experience with mr-guided focused ultrasound thalamotomy, parkinsonism & related disorders, nov 24, 2019). According to the article, six months after the treatment, patient's right upper extremity dystonia worsened substantially. This degree of dystonia limited daily activities that he had temporarily re-gained following tremor reduction with thalamotomy. No other motor/sensory change was observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2020-00003 |
| MDR Report Key | 9785021 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-02-09 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2020-03-04 |
| 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. MEITAL TRANK |
| 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 |
| 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 | EXABLATE 4000 |
| Generic Name | MR GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2020-03-04 |
| Model Number | 4000 |
| Catalog Number | SYS940300 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-04 |