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	High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a revision procedure for an unknown reason.The physician replaced the entire system.The current location of the explanted devices remains unknown.No additional information was available.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Product family: scs-linear leads-mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 20127716.Udi: (b)(4).Product family: scs-linear leads-mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 20127716.Udi: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a revision procedure for an unknown reason.The physician replaced the implantable pulse generator (ipg).The current location of the explanted ipg remains unknown.No additional information was available.Additional details confirm that the spinal cord stimulation (scs) patient underwent an explant procedure as part of an elective device replacement.The patient is recovering well postoperatively and has expressed satisfaction with the ongoing therapy.In accordance with facility policy, the explanted device was disposed of and will not be returned.As there are no reportable allegations related to device performance and no serious injury was sustained, the complaint has been downgraded as non-reportable based on these criteria.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Product family: scs-linear leads-mri, upn: m365sc2408740, model: sc-2408-74, serial: (b)(6), batch: 20127716, udi: (b)(4).Product family: scs-linear leads-mri, upn: m365sc2408740, model: sc-2408-74, serial: (b)(6), batch: 20127716, udi: (b)(4).
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Product family: scs-linear leads-mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 20127716.Udi: (b)(4).Product family: scs-linear leads-mri.Upn: m365sc2408740.Model: sc-2408-74.Serial: (b)(6).Batch: 20127716.Udi: (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent a revision procedure for an unknown reason.The physician replaced the implantable pulse generator (ipg).The current location of the explanted ipg remains unknown.No additional information was available.Additional details confirmed that the spinal cord stimulation (scs) patient underwent an explant procedure as part of an elective device replacement.The patient is recovering well postoperatively and has expressed satisfaction with the ongoing therapy.In accordance with facility policy, the explanted device was disposed of and will not be returned.Additional information confirmed high impedances were found on the leads.

• 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 ; EI 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22766512
• Report Number: 3006630150-2025-06328
• Device Sequence Number: 20866597
• Product Code: LGW
• UDI-Device Identifier: 08714729907114
• UDI-Public: (01)08714729907114(17)190623(10)307120
• 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: 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): 11/06/2025

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: 06/23/2019
• Device Model Number: SC-1210B
• Device Catalogue Number: SC-1210B
• Device Lot Number: 307120
• 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: 07/17/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 10/13/2025
• Initial Report FDA Received Date: 08/09/2025
• Supplement Report FDA Received Date: 09/15/2025; 11/06/2025
• 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: Female