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

Model Number	SC-6412-3
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sustained a second-degree burn from the spinal cord stimulator (scs) charger.The patient informed that they tucked the charger into their pants and it got really hot during charging.The patient then noted sensitivity and redness at the implant site and went to the emergency room.Steroid cream was applied which helped a bit and the patient was also advised to use bacitracin ointment for healing.The patient was educated on best practices for charging.
Event or Problem Description
It was reported that the patient sustained a second-degree burn from the spinal cord stimulator (scs) charger.The patient informed that they tucked the charger into their pants and it got really hot during charging.The patient then noted sensitivity and redness at the implant site and went to the emergency room.Steroid cream was applied which helped a bit and the patient was also advised to use bacitracin ointment for healing.The patient was educated on best practices for charging.Additional information was received that the burn site has improved and healing was observed.The patient was doing well.No next course of action.

• Brand Name: Precision?
• 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 24659268
• Report Number: 3006630150-2026-01702
• Device Sequence Number: 21138833
• Product Code: LGW
• UDI-Device Identifier: 08714729821243
• UDI-Public: (01)08714729821243(10)462565
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: SC-6412-3
• Device Catalogue Number: SC-6412-3
• Device Lot Number: 462565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 09/02/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/01/2026; 09/25/2026
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 37 YR
• Patient Sex: Female