MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for TMS TREATMENT FOR MAJOR DEPRESSION manufactured by Neuronetics, Inc..
[113263212]
Hi. I'm contacting you because a very good friend of mine (a professional with a 6-figure income) diagnosed with bipolar disorder went off of his medications after he had tms about 1 year ago. One year later, his relationships are in shambles. Previously financially conservative, he has now accumulated (b)(6) of debt (i. E. Has purchased 2 houses, 3 boats, 4 cars for starters), he is drinking heavily and his job of 18 yrs is now in jeopardy d/t irrational behavior at work. All of this is very out-of-character for him! Tms is ruining his life. He won't listen to family and friends. He is completely out of control. You approved this therapy. What now. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[113950061]
Add'l info received from reporter on july 11, 2018 for mw5078207. He believed in tms and thinks he's cured. His job is in jeopardy because of irrational behavior at work, he has been spending compulsive (purchased 2 boats, an airplane, 2 rvs). He has been drinking excessively of bizarre behavior. (b)(6) had a full blown panic attack over the weekend and called 911 on himself. He was diverted to a treatment facility and held for 48 hrs against his will on a high risk suicide watch. He was released today and is back in his hypo-manic state, still refusing medications and accused the medical providers of "overreacting. " i have called clinics in the area ((b)(6)) who provide tms therapy and they are "washing their hands clean" of responsibility saying he needs to f/u with pcp or his psychiatrist. I am hoping that the fda hears this. Major depression and bipolar disorders are in a different class from minor depression and migraines, and there's very or little f/u for these pts. I know of one person who could have a deadly outcome here and someone is going to be liable for this tragedy. How many more are like him out there. I can assure you that the tms clinics who are taking in hundreds of thousands of dollars cash to treat these pts have no clue. I wonder if (b)(6) and (b)(6) had tms. Please take action here and mandate proper long-term f/u. Dates of use: 1 year. Diagnosis or reason for use: major depression / bipolar disorder. "is the product compounded: no; is the product over-the-counter: no. " (b)(6), rn, bsn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078207 |
| MDR Report Key | 7658337 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-07-06 |
| Date Added to Maude | 2018-07-03 |
| 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 |
| 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 | TMS TREATMENT FOR MAJOR DEPRESSION |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2018-07-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Other | 2018-07-02 |