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

Model Number	SC-3400-30
Medical Device Problem Codes	Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Cut In Material (2454)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-2316-50 serial #: (b)(4) description: infinion 1x16 perc lead kit50cm model#: sc-3400-30 serial #: (b)(4) description:infinion splitter 2x8 kit30 cm model#: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator model#: sc-4316 lot #: 16240019 description: next generation anchor kit-sterile the explanted clik anchor was not returned to bsn as it was discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device 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 inadequate stimulation due to high impedances.The physician suspected that the splitters were corrupted.The patient underwent a revision procedure wherein the ipg, leads, and clik anchor were replaced.During the explant, the leads and splitters were cut around the scar tissue.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Sc-2316-50 (b)(4) device evaluation indicated that the complaint has been confirmed.Visual inspection found that lead was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 19 cm from the tip of distal end.X-ray inspection confirmed 11cables were fractured (electrodes 1, 2, 4, 6-9, 13-16).There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Sc-2316-50 (b)(4) device evaluation indicated that the complaint has been confirmed.Visual inspection found that lead was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 24 cm from the tip of distal end.X-ray inspection confirmed all cables were fractured.There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Sc-3400-30 (b)(4) device evaluation indicated that the source of the complaint in regard to the high impedances was verified to be with the associated leads.Visual inspection revealed that the lead splitters were cleanly cut at 21 cm from proximal ends.X-ray inspections found no cable breakage.The clean cut damage is a result of a typical explant procedure and it is not considered a failure.Sc-1132 (b)(4) device evaluation indicated that the complaint in regard to the high impedances was verified to be with the associated leads.The ipg passed all the required tests and revealed normal device characteristics.Sc-4316 lot #: 16240019 it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device 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 inadequate stimulation due to high impedances.The physician suspected that the splitters were corrupted.The patient underwent a revision procedure wherein the ipg, leads, and clik anchor were replaced.During the explant, the leads and splitters were cut around the scar tissue.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: 6772727
• Report Number: 3006630150-2017-02875
• Device Sequence Number: 1736137
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: 08714729797838
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/17/2017

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: 11/28/2014
• Device Model Number: SC-3400-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR