MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Precision Novi?; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-1140
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/10/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced shocking sensation and inadequate pain relief from the spinal cord stimulator (scs) system despite program optimization attempts.The patient subsequently underwent an scs system explant procedure.No further information could be obtained.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in 2016.Block d.6b; explant date: 2016.Additional suspect medical device components involved in the event: model number/catalog number: sc-2158-70.Serial number: (b)(6).Batch/lot number: 18290445.Model/catalog description: linear lead kit 70 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2158-70.Serial number: (b)(6).Batch/lot number: 18290445.Model/catalog description: linear lead kit 70 cm.Unique identifier (udi) #: (b)(4).

• Brand Name: Precision Novi?
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50081373
• Report Number: 3006630150-2026-05406
• Device Sequence Number: 18696779
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)180427(10)19179767
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 04/27/2018
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 19179767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 04/27/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female