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 Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50 serial number: (b)(6).Batch/lot number: 7056455 model/catalog description: linear st lead kit 50 cm unique identifier (udi): (b)(4).Model number/catalog number: sc-2218-50 serial number: (b)(6).Batch/lot number: 5158913 model/catalog description: linear st lead kit 50 cm unique identifier (udi): (b)(4).Model number/catalog number: sc-4316 serial number: na batch/lot number: 23645910 model/catalog description: clik anchor unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that the patient was allergic to the spinal cord stimulator (scs) device and was not receiving adequate pain relief from the therapy.As a result, the patient underwent an scs system explant procedure and was doing well postoperatively.The explanted device components were not able to be returned.

• 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; cashel road; clonmel
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25884316
• Report Number: 3006630150-2026-05124
• Device Sequence Number: 10017544
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)210619(10)201801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: 06/19/2021
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 201801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 06/20/2019
• 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: 39 YR
• Patient Sex: Female