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	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred a few years ago.Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50, serial number: (b)(6), batch/lot number: 5025745, 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: 21542458, model/catalog description: linear st lead kit 50 cm, unique identifier (udi)#: (b)(4), model number/catalog number: sc-4318, serial number: na, batch/lot number: 23131025, model/catalog description: clik x anchor sterile kit, unique identifier (udi)#: (b)(4).
Event or Problem Description
It was reported that the patient experienced overstimulation from the spinal cord stimulator (scs) device.The patient underwent an scs system explant procedure.No further information could be obtained.
Event or Problem Description
It was reported that the patient experienced overstimulation from the spinal cord stimulator (scs) device.The patient underwent an scs system explant procedure.No further information could be obtained.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred a few years ago.Block d6b: explant date: few years ago.Additional suspect medical device components involved in the event: model number/catalog number: sc-2218-50, serial number: (b)(6), batch/lot number: 5025745, 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: 21542458, model/catalog description: linear st lead kit 50 cm, unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4318, batch/lot number: 23131025, model/catalog description: clik x anchor sterile kit, unique identifier (udi) #: (b)(4).Investigation results: the devices were not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the devices, however response was not received.Device history record: it was confirmed these devices met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.

• 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 ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 24845889
• Report Number: 3006630150-2026-02239
• Device Sequence Number: 17558672
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)210309(10)201443
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 03/09/2021
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 201443
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 03/10/2019
• 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: 61 YR
• Patient Sex: Male