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

Model Number	SC-3400-30
Medical Device Problem Codes	High impedance (1291); Defective Component (2292)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model #: sc-2316-50 serial #: (b)(4) description: infinion 1x16 perc lead kit-50cm model #: sc-3400-30 serial #: (b)(4) description: infinion splitter 2x8 kit (30cm) the explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that the patient was experiencing loss of stimulation.High impedances were noted.The patient underwent a revision procedure wherein the leads were replaced and the splitters were explanted.During the intraoperative testing, it was confirmed that the splitters were known to be the problem of defect.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Correction to the initial mdr should have been: (b)(6) 2017.
Event or Problem Description
A report was received that the patient was experiencing loss of stimulation.High impedances were noted.The patient underwent a revision procedure wherein the leads were replaced and the splitters were explanted.During the intraoperative testing, it was confirmed that the splitters were known to be the problem of defect.The patient was doing well postoperatively.

• 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: 7032958
• Report Number: 3006630150-2017-04623
• Device Sequence Number: 10794628
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/25/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR