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	Nausea (1970); Pain (1994); Vomiting (2144)
Date of Event	02/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's spinal cord stimulation (scs) was causing nausea, vomiting, more pain than it was before the device was implanted.The patient underwent a procedure wherein the implantable pulse generator (ipg) and spinal cord stimulator (scs) leads were explanted.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-2352-70.Serial number: (b)(6).Batch/lot number: 19991394.Model/catalog description: linear 3-4 lead 70 cm.Unique identifier (udi)#:(b)(4).Model number/catalog number: sc-2352-70.Serial number: (b)(6).Batch/lot number: 20134709.Model/catalog description: linear 3-4 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50140790
• Report Number: 3006630150-2026-05573
• Device Sequence Number: 18817770
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)190112(10)20156293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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: 01/12/2019
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 20156293
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 01/12/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male