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 Codes	Overheating of Device (1437); Charging Problem (2892)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Burning Sensation (2146)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing difficulty charging the implantable pulse generator (ipg).The charger would get extremely hot when charging and patient noted actual burns on the back, burning sensation from the inside out, and redness over the battery site and entire spine area.The patient was provided with a new charger, had a program optimization done and is currently doing well.
Event or Problem Description
It was reported that the patient was experiencing difficulty charging the implantable pulse generator (ipg).The charger would get extremely hot when charging and patient noted actual burns on the back, burning sensation from the inside out, and redness over the battery site and entire spine area.The patient was provided with a new charger, had a program optimization done and is currently doing well.
Additional Manufacturer Narrative
Sc-6412-3 (sn (b)(6).Investigation results: the charger was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: a labeling review was conducted and determined that the reported event is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation (scs).The event is consistent with risks disclosed in the device labeling.Risk review: a risk review was completed and confirmed that the event of overheating of device, difficulty charging and burn was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the investigation was limited to the information and documentation available at the time of review.Evaluation of the complaint record did not identify objective evidence to confirm the reported allegation or determine a cause, therefore, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 25786434
• Report Number: 3006630150-2026-04841
• Device Sequence Number: 18548059
• Product Code: LGW
• UDI-Device Identifier: 08714729821243
• UDI-Public: (01)08714729821243(10)524603
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/17/2026

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: 524603
• 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: 06/18/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 08/11/2025
• 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: Other
• Patient Age: 44 YR
• Patient Sex: Female