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 Codes	Bacterial Infection (1735); Head Injury (1879)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: db-2201-30dc serial #: (b)(4) description: 30 cm twist lead, 0.016 tungsten stylet model #: nm-3138-55 serial #: (b)(4), 1073209 description:55 cm 8 contact extension kit the devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the leads and lead extensions 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 banged his head.Scabs and an infection appeared at the lead insertion site of the cranial leads.The patient was hospitalized and received iv antibiotics starting on 10-apr-2017, for 6 weeks.The patient then underwent an explant procedure where the cranial leads and lead extensions were removed on (b)(6) 2017.The infection has resolved and the patient is doing well.The physician assessed that the infection was not severe and it is unknown if the infection was related to the device or the procedure.

• 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: 7332803
• Report Number: 3006630150-2018-00996
• Device Sequence Number: 13822222
• Product Code: NHL
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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: 08/23/2018
• Device Model Number: DB-2201-30DC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/12/2018
• 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