MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for FOCUSED MAGNETIC ULTRASOUND FOR CENTRAL TREMORS manufactured by Insightec, Ltd..
[102244886]
Reporter alleges she had focused ultrasound on the left side of her brain to decrease tremors on her right hand. This procedure was done at (b)(6) hospital in (b)(6) where she had to pay $(b)(4) upfront. Allegedly, she was told the procedure is painless and its an in and out procedure, not only did she experience excruciating pain she also had an overnight stay for observation. She also felt ignored when she was in distress and it felt like she was in a torture chamber. Reporter believes the procedure was highly unsuccessful and expensive for something that did not work for her. She alleges her tremors have gotten worse, she was incoherent after the procedure, her scalp hurts and she has dizzy spells.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075783 |
| MDR Report Key | 7330339 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2017-10-18 |
| Date Added to Maude | 2018-03-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | FOCUSED MAGNETIC ULTRASOUND FOR CENTRAL TREMORS |
| Generic Name | MR-GUIDED FOCUSED ULTRASOUND SYSTEM |
| Product Code | POH |
| Date Received | 2018-03-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSIGHTEC, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-09 |