MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-05-31 for NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[76318498]
B. 3. Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in the published literature. Medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned". These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76318499]
Blomstedt, p. , naesstr? M, m. , bodlund, o. Deep brain stimulation in the bed nucleus of the stria terminalis and medial forebrain bundle in a patient with major depressive disorder and anorexia nervosa. Clinical case reports. 2017. Doi: 10. 1002/ccr3. 856 summary: deep brain stimulation (dbs) may be considered in severe cases of therapy-refractory major depressive disorder (mdd). However, dbs for mdd is still an experimental therapy. Therefore, it should only be administered in clinical studies driven by multidisciplinaryteams, including surgeons with substantial experience of dbs in the treatment of other conditions. Reported event: a (b)(6) woman with bilateral deep brain stimulation (dbs) in the area of the medial forebrain bundle (mfb) in the posterior hypothalamic area for the treatment of major depressive disorder (mdd) with comorbid anorexia nervosa experienced significant therapeutic benefit initially, but stimulation could not be advanced beyond 2. 8 v on the left side and 3. 0 v on the right as it caused blurred vision. Ten months after the procedure the patient complained of blurred vision, which multiple readjustments of stimulation parameters and the cessation of lamotrigine did not resolve. The authors stated that the symptom was partly stimulation induced but even after the stimulation had been turned off for 2 weeks, some minor symptoms remained. The stimulation was restarted with a voltage reduced to a level where the side effects were tolerable, however, with a reduced effect on her psychiatric symptoms. The authors subsequently concluded that the patient was indicated for the implant of additional leads, and the patient was implanted with bilateral leads targeting the bed nucleus of the stria terminalis (bnst). The patient received monopolar stimulation through two contacts on each electrode with a gradually increasing voltage. At 12 months, the patient received 130 hz, 120? Sec and 4. 3 v bilaterally. The stimulation in the mfb was reduced and turned off simultaneously without any signs of deterioration. The patient then experienced gradual but? Very profound? Improvement. Nine months after surgery, the patient was released from the psychiatric ward and returned to her home. Prior to this, she had been subject to hospital care, initially, due to her eating disorder and lastly due to severe mdd with suicidal ideation, for almost 4 years. She is now living full time at home with her family and is participating in social gatherings and outdoor activities. She considers herself to be profoundly improved, and at 12 months, her madrs was reduced to 13 points, with an ham-d score of six and an ham-a of 5 points. Following this second procedure all of the patient? S anxiety concerning food and eating vanished. The patient was reportedly implanted with model 3389 leads targeting the medial forebrain bundle, and 3387 leads were later implanted targeting the bed nucleus of the stria terminalis. It was not possible to ascertain any additional specific device information from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
[98781077]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-02104 |
| MDR Report Key | 6602658 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-31 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2017-05-08 |
| Date Added to Maude | 2017-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MFR |
| Date Received | 2017-05-31 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-31 |