MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-12 for EXABLATE 4000 manufactured by Insightec Ltd.
[187758885]
The (b)(6) post could not be confirmed with the treating physician not enough details to locate the site or the specific treatment. Not enough details to investigate
Patient Sequence No: 1, Text Type: N, H10
[187758886]
This complaint was posted on insightec (b)(6) page. The patient stated that she had brain treatment for essential tremor on (b)(6) 2018 and since then she had "lots of effects: high bp, headaches and tongue nerves damaged". The patient also reported that some of the side effects "got better like balance" (no further details). Based on the available information, the company has no ability to locate the site or the treating physician. The complainant received a post back that she should reach her treating physician or contact insightec formal website. No further information was received regarding this case so far.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2020-00005 |
| MDR Report Key | 9823076 |
| Report Source | OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| Model Number | 4000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-12 |