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	Nonstandard Device (1420); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulator (scs) was no longer working and patient experienced loss of stimulation.The patient underwent spinal cord stimulator (scs) explant procedure.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred four years ago.Block d6b: explant date: four years ago.Additional suspect medical device component involved in the event: model number/catalog number: sc-8216-70.Serial number: (b)(6) batch/lot number: (b)(6) model/catalog description: artisan lead 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; cashel road; clonmel ; EI
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50058984
• Report Number: 3006630150-2026-05352
• Device Sequence Number: 10687343
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2021
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 201836
• 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: 06/30/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 07/02/2019
• 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 Sex: Male