MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE; DEEP BRAIN STIMULATOR

Model Number	DB-2201-30DC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model # db-2201-30dc, serial # (b)(4).Description: thirty (30) cm twist lead, 0.016 tungsten stylet model # db-1110c, serial # (b)(4).Description: vercisetm implantable pulse generator kit a review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
Event or Problem Description
A report was received that the patient experienced a moderate gait disturbance.The patient was admitted, administered medication and the device was reprogrammed.The event has resolved and was assessed as not related to the procedure or to the device hardware.

• Brand Name: VERCISE
• Common Device Name: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7176598
• Report Number: 3006630150-2017-05526
• Device Sequence Number: 1786265
• Product Code: NHL
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/07/2018
• Device Model Number: DB-2201-30DC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention