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 Code	Pain (1994)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate pain relief.All device components were explanted and discarded by the medical facility.The patient was doing well.
Additional Manufacturer Narrative
Block b3: exact date unknown, approximated based on the explant date.Additional suspect medical device components involved in the event: model number/catalog number: sc-2352-50.Serial number: (b)(6).Batch/lot number: 5001130.Model/catalog description: lin.Ear 3-4 lead 50 cm.Unique identifier (udi) #: (b)(4) model number/catalog number: sc-2352-50.Serial number: (b)(6).Batch/lot number: 5001135.Model/catalog description: linear 3-4 lead 50 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4316.Batch/lot number: 21942593.Model/catalog description: clik anchor.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: 50944963
• Report Number: 3006630150-2026-07221
• Device Sequence Number: 21439869
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• 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: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 02/09/2020
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 21660367
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 02/09/2018
• 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: 72 YR
• Patient Sex: Female