MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION®; SPINAL CORD STIMULATOR

Model Number	SC-3400-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-3400-30 serial #:(b)(4), description: infinion splitter 2x8 kit, 30 cm.
Event or Problem Description
A report was received that the products were returned for an unknown reason.
Additional Manufacturer Narrative
Additional information was received that the products returned were never implanted and that they were expiring.
Event or Problem Description
A report was received that the products were returned for an unknown reason.

• Brand Name: PRECISION®
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6233534
• Report Number: 3006630150-2017-00054
• Device Sequence Number: 955744
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: (01)08714729797838(17)161116(10)17458922
• Combination Product (Y/N): N
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2016

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: 11/16/2016
• Device Model Number: SC-3400-30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 04/03/2017
• 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: Required Intervention