MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for EXABLATE NEURO manufactured by Insightec Haifa Israel, Insightec, Ltd..
[107379850]
For tremor dominant idiopathic parkinson treatment mrgfus device "exablate neuro" of manufacturer (b)(4), (b)(4) reached not the prescribed temperature of ablation with mri guided focused ultrasonic therapy and failed due to physical parameters which were out of tolerance. Ongoing clinical trial (b)(6) should implement the knowledge of parameters, essentially to reach successful treatment, as they are: skullsize, the adapter has to fit optimized in head size diameter, skull density ratio has to be above 0. 5, skin inclusions in forehead, no present particles in skin allowed, disturbing the focusing of beam, metallic teeth implants reflect ultrasound beam and overheat side-parts due to these parameters, which were not met, a successful treatment was not possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076988 |
| MDR Report Key | 7482440 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-01 |
| Date of Event | 2016-02-19 |
| Date Added to Maude | 2018-05-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXABLATE NEURO |
| Generic Name | MR - GUIDED FOCUSED ULTRASOUND |
| Product Code | POH |
| Date Received | 2018-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC HAIFA ISRAEL, INSIGHTEC, LTD. |
| Brand Name | EXABLATE NEURO |
| Generic Name | MR - GUIDED FOCUSED ULTRASOUND |
| Product Code | LSY |
| Date Received | 2018-05-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC HAIFA ISRAEL, INSIGHTEC, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-05-02 |