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

Model Number DB-2201-30DC

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 10/04/2017

Event Type  Injury  

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 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
• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7176598
• MDR Text Key: 96783024
• Report Number: 3006630150-2017-05526
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/07/2018
• Device Model Number: DB-2201-30DC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• 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): Hospitalization; Required Intervention