MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3400-30
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	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Product family: scs-splitters.Upn: m365sc2218500.Model: sc-3400-30.Serial: (b)(6).Batch: 17421728.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.

• Brand Name: NA
• 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: 23018961
• Report Number: 3006630150-2025-07426
• Device Sequence Number: 15908806
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: (01)08714729797838(17)161208(10)17490443
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 09/10/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/08/2016
• Device Model Number: SC-3400-30
• Device Catalogue Number: SC-3400-30
• Device Lot Number: 17490443
• 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: 08/15/2025
• Initial Report FDA Received Date: 09/10/2025
• Date Device Manufactured: 12/08/2014
• 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: 76 YR
• Patient Sex: Female