MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-20 for RECLAIM DEEP BRAIN STIMULATION manufactured by Medtronic.
[106264770]
Two women committed suicide on (b)(6) 2018 in (b)(6), both women received deep brain stimulation for obsessive compulsive disorder in 2015 by dr. (b)(6) in (b)(6). Newspaper story reported the deaths on april 4, 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076615 |
| MDR Report Key | 7450218 |
| Date Received | 2018-04-20 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-03-30 |
| Date Added to Maude | 2018-04-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RECLAIM DEEP BRAIN STIMULATION |
| Generic Name | DEEP BRAIN STIMULATION |
| Product Code | OLM |
| Date Received | 2018-04-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-04-20 |