MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; 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	11/01/2017
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 patient underwent a lead revision procedure for an unknown reason.
Additional Manufacturer Narrative
Additional information was received that the reason for the patients revision was loss of stimulation due to high impedance as reported in mfr report #: 3006630150-2017-04623.The patient underwent a revision procedure wherein the splitters were explanted.The patient was doing well postoperatively.
Event or Problem Description
A report was received that the patient underwent a lead revision procedure for an unknown reason.

• Brand Name: PRECISION SPECTRA
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7046428
• Report Number: 3006630150-2017-04675
• Device Sequence Number: 1916012
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: 08714729797838
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 10/11/2014
• Device Model Number: SC-3400-30
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/07/2017
• 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
• Patient Age: 54 YR