MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Precision Montage ? MRI; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	SC-1210B
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Inappropriate Device Stimulation of Tissue (4928)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate pain relief from the device.Additionally, increasing the stimulation to higher settings resulted in undesired sensations, including foot twitching and a rubber band-like sensation, which made walking difficult.The patient underwent implantable pulse generator (ipg) explant procedure.
Additional Manufacturer Narrative
Investigation result: the device was not returned to boston scientific for analysis.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.Labeling review: a labeling review did not reveal any anomalies as it states: system failure, which can occur at any time due to random failure(s) of the components or the battery.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control and undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure are a known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.Risk review: a risk review was completed and confirmed that the event of stimulation inadequate, difficult to upgrade ipg firmware was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of known inherent risk of device was assigned to the investigation for all components.

• Brand Name: Precision Montage ? MRI
• 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: 50201441
• Report Number: 3006630150-2026-05715
• Device Sequence Number: 5521678
• Product Code: LGW
• UDI-Device Identifier: 08714729907114
• UDI-Public: (01)08714729907114(17)190623(10)307077
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 06/23/2019
• Device Model Number: SC-1210B
• Device Catalogue Number: SC-1210B
• Device Lot Number: 307077
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 06/23/2017
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 205 LB