MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Therapeutic Effects, Unexpected (2099); Cognitive Changes (2551)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

Please note that this event date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Concomitant medical products: product id neu_unknown_lead, lot# unknown, product type: lead; product id neu_unknown_lead, lot# unknown, product type: lead.(b)(4).

Event Description

Luyten, l., hendrickx, s., raymaekers, s., gabriels, l., nuttin, b.Electrical stimulation in the bed nucleus of the stria terminalis alleviates severe obsessive-compulsive disorder.Molecular psychiatry.2015.1-9.Doi: 10.1038/mp.2015.124.Summary: in 1998, we proposed deep brain stimulation as a last-resort treatment option for patients suffering from severe, treatment-resistant obsessive-compulsive disorder (ocd).Here, 24 ocd patients were included in a long-term follow-up study to evaluate the effects of electrical stimulation in the anterior limbs of the internal capsule (alic) and bed nucleus of the stria terminalis (bst).We find that electrical stimulation in the alic/bst area is safe and significantly decreases obsessions, compulsions, and associated anxiety and depressive symptoms, and improves global functioning in a blinded crossover trial (n = 17), after 4 years (n = 18), and at last followup (up to 171 months, n = 24).Moreover, our data indicate that bst may be a better stimulation target compared with alic to alleviate ocd symptoms.We conclude that electrical stimulation in bst is a promising therapeutic option for otherwise treatment resistant ocd patients.Reported events: patient 17: one (b)(6) male patient with bilateral deep brain stimulation (dbs) targeting the bed nucleus of the stria terminalis (bst) to treat obsessive compulsive disorder (ocd) did not enter the crossover part of the study because they only experienced only a "slight improvement," with a 26/40 being their lowest yale-brown obsessive-compulsive scale (y-bocs) score, and a worse score of 36 at last follow-up, equating to a 10% improvement versus their preoperative score.The patient ultimately underwent electrode removal and capsulotomy after 28 months.Further information has been requested; a supplemental report will be submitted if additional information is received.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5154529
• MDR Text Key: 28436885
• Report Number: 3007566237-2015-02985
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Health Professional
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• 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: 09/17/2015
• 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: 00034 YR