MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-15 for RECLAIM DEEP BRAIN STIMULATOR FOR OCD SOLETRA 7426 manufactured by Medtronic.
[80215153]
On (b)(6) 2010, i was implanted with reclaim deep brain stimulator for obsessive compulsive disorder. I was told by doctor (b)(6). That the device was being implanted to improve my depression. Much paperwork was withheld from me before the implant. I had horrible problems with the device (either severe mania or severe suicidal ideation). Before and after the implant, dr (b)(6) had me addicted to 90 mg of oxycodone and a laundry list of other medications. I do not and never had ocd. You can go to a (b)(6) page i dedicated to this and other crimes committed against me by the (b)(6). Here is the link (b)(6). On this page you will hear dr (b)(6). In his own words, admit false diagnoses, (b)(6) fraud and false claims violations in only one of the video post. Please review the entire page to see the other things done to me and you will see the condition i am in now. I now live in the (b)(6) for fear of my freedom. If you want any info or want me to call you please email me at (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071024 |
| MDR Report Key | 6718775 |
| Date Received | 2017-07-15 |
| Date of Report | 2017-07-15 |
| Date of Event | 2010-08-17 |
| Date Added to Maude | 2017-07-17 |
| 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 | 3 |
| Brand Name | RECLAIM DEEP BRAIN STIMULATOR FOR OCD |
| Generic Name | RECLAIM DEEP BRAIN STIMULATOR FOR OCD |
| Product Code | OLM |
| Date Received | 2017-07-15 |
| Model Number | SOLETRA 7426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 2 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit | 2017-07-15 |