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	High impedance (1291); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an implantable pulse generator (ipg) replacement procedure due to an unknown reason.No further information could be obtained despite good faith efforts.
Event or Problem Description
It was reported that the patient underwent an implantable pulse generator (ipg) replacement procedure due to an unknown reason.No further information could be obtained despite good faith efforts.Additional information was received that the patients implantable pulse generator (ipg) was replaced due to difficulty charging wherein a nonrechargeable ipg was implanted.The patient was doing well postoperatively.The explanted ipg device was kept by the medical facility.
Event or Problem Description
It was reported that the patient underwent an implantable pulse generator (ipg) replacement procedure due to an unknown reason.No further information could be obtained despite good faith efforts.Additional information was received that the patients implantable pulse generator (ipg) was replaced due to difficulty charging wherein a nonrechargeable ipg was implanted.The patient was doing well postoperatively.The explanted ipg device was kept by the medical facility.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: based on all available information, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 24662988
• Report Number: 3006630150-2026-01707
• Device Sequence Number: 9290028
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 09/06/2019
• Device Model Number: SC-1140
• Device Catalogue Number: SC-1140
• Device Lot Number: 21096621
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/15/2026; 05/15/2026
• Date Device Manufactured: 09/06/2017
• 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: Required Intervention
• Patient Sex: Female