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

Model Number	SC-3138-25
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: qrb.Block b3: exact date unknown, event occurred in approximately right after the battery replacement procedure from date manufacturer was made aware.Additional suspect medical device component involved in the event: product family: scs-paddle leads.Upn: m365sc8216700.Model: sc-8216-70.Serial: (b)(6).Batch: 15968904.Udi: (b)(4).
Event or Problem Description
It was reported that the patients spinal cord stimulator paddle lead demonstrated impedance concerns.During the procedure, the physician was unable to advance the paddle lead and was only able to disconnect it from the extension.Consequently, only the extension component was explanted.The patient tolerated the procedure well and was reported to be in stable condition postoperatively.

• 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: 22679874
• Report Number: 3006630150-2025-06025
• Device Sequence Number: 9566101
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: (01)08714729760542(17)180125(10)18807129
• 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: 2016
• 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): 07/31/2025

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: 01/25/2018
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 18807129
• 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: 07/14/2025
• Initial Report FDA Received Date: 07/31/2025
• 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: 56 YR
• Patient Sex: Female