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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block b2 and b3: date approximate based on boston scientific aware date of event.
Event or Problem Description
It was reported that the patient passed away which was found through a patient outreach call.It was reported that it was not known if the passing was device related.There was no allegation of patient harm caused by the device or by a device related procedure.The physician was not aware of the passing.No further information can be obtained.

• 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 ; 7632920920
• MDR Report Key: 25341223
• Report Number: 3006630150-2026-03647
• Device Sequence Number: 14762225
• Product Code: LGW
• UDI-Device Identifier: 08714729897835
• UDI-Public: (01)08714729897835(17)190810(10)20988633
• 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: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 08/10/2019
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 20988633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/31/2026
• Date Device Manufactured: 08/10/2017
• 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: Death
• Patient Sex: Male