Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.

• Trade Name: Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD) System
• Classification Name: deep brain stimulator for obsessive compulsive disorder (ocd)
• Generic Name: deep brain stimulator for obsessive compulsive disorder (ocd)
• Applicant: MEDTRONIC INC.,NEUROLOGICAL DIVISION; 7000 central avenue northeast; minneapolis, MN 55432
• HDE Number: H050003
• Supplement Number: S169
• Date Received: 09/20/2017
• Decision Date: 10/20/2017
• Product Code: OLM [ Registered Establishments with OLM ]
• Advisory Committee: Neurology
• Supplement Type: special (immediate track)
• Supplement Reason: labeling change - indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of new safety information (tunneling procedure unintended nerve tissue injury warning and adverse event, loss of coordination precaution, weight gain/loss adverse event) and safety enhancement clarifications (update guidance on avoiding damage to the neurostimulator (physician labeling), clarify text that accompanies the figure for accurate right and left hemisphere lead-extension connection when placing dual lead systems (physician labeling), remove incorrect length of the dbs lead placed under the scalp (patient labeling)).