MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Therapeutic Response, Decreased (2271)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Blomstedt, p., naesström, 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.

Manufacturer Narrative

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.

• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6602658
• MDR Text Key: 76318498
• Report Number: 3007566237-2017-02104
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR