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 Codes	Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-lead fixation-mri upn: m365sc43190 model: sc-4319 serial: na batch: 20140611 udi: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent an explant procedure wherein the implantable pulse generator (ipg) and a clik anchor were removed for an unknown reason.No additional information is available at this time.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-lead fixation-mri upn: m365sc43190, model: sc-4319, serial: na, batch: 20140611, udi: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent an explant procedure wherein the implantable pulse generator (ipg) was removed for an unknown reason.No additional information has been obtained at this time.Additional information was received that the ipg was no longer working.The patient experienced a return of their pain and wanted a primary cell battery.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent an explant procedure wherein the implantable pulse generator (ipg) was removed for an unknown reason.No additional information has been obtained at this time.Additional information was received that the ipg was no longer working.The patient experienced a return of their pain and wanted a primary cell battery.
Additional Manufacturer Narrative
The explanted ipg and anchor were not returned; therefore, a physical analysis could not be performed.A review of the device history record (dhr) confirmed that the devices met all applicable specifications prior to release for distribution.No manufacturing deviations were identified that could have contributed to the reported event.Additionally, a review of the product labeling for the ipg was conducted and did not identify any anomalies.The labeling states that system failure may occur at any time due to random component or battery failure.Known risks associated with spinal cord stimulation systems include device failure, lead breakage, hardware malfunction, loose connections, electrical shorts or open circuits, and lead insulation breaches, which may result in ineffective pain control.Additionally, the labeling identifies that undesirable stimulation may occur over time due to tissue changes around the electrodes, changes in electrode position, loose electrical connections, and/or lead failure.Additional suspect medical device component involved in the event: model: sc-4319.Serial: na.Batch: 20140611.Model/catalog description: clik x mri anchor.Udi: (b)(4).

• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23796703
• Report Number: 3006630150-2025-11435
• Device Sequence Number: 5547082
• Product Code: LGW
• UDI-Device Identifier: 08714729907114
• UDI-Public: (01)08714729907114(17)200109(10)352621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 01/09/2020
• Device Model Number: SC-1210B
• Device Catalogue Number: SC-1210B
• Device Lot Number: 352621
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 03/06/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/14/2026; 03/10/2026
• Date Device Manufactured: 01/09/2018
• 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: 68 YR
• Patient Sex: Female