MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LEAD KIT 30CM; 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	Unspecified Infection (1930)
Date of Event	03/20/2018
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: 30 cm twist lead, 0.016 tungsten stylet.
Event or Problem Description
A report was received that the patient was admitted due to ongoing headaches increasing in severity and a continued infection at the ipg site following an ipg explant procedure, previously reported in mfr# 3006630150-2018-01150.The patient underwent an explant procedure of the leads and lead extensions, and was then discharged.The patient is recovering and the event is resolving.The event was reported as being causally related to the procedure and hardware, leads and ipg, and not related to the study device stimulation.No device malfunction was suspected.
Additional Manufacturer Narrative
Initial mdr should have been (b)(6) 2018 additional suspect medical device components involved in the event: model: nm-3138-55 serial: (b)(4) description: 55 cm 8 contact extension kit no additional information is provided per clinical study protocol.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 was admitted due to ongoing headaches increasing in severity and a continued infection at the ipg site following an ipg explant procedure, previously reported in mfr# 3006630150-2018-01150.The patient underwent an explant procedure of the leads and lead extensions, and was then discharged.The patient is recovering and the event is resolving.The event was reported as being causally related to the procedure and hardware, leads and ipg, and not related to the study device stimulation.No device malfunction was suspected.

• Brand Name: LEAD KIT 30CM
• Common Device Name: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7487290
• Report Number: 3006630150-2018-01575
• Device Sequence Number: 18871877
• Product Code: NHL
• UDI-Device Identifier: 08714729836490
• UDI-Public: 08714729836490
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 04/05/2019
• Device Model Number: DB-2201-30DC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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