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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a burn.The physician provided wound care to patient.
Additional Manufacturer Narrative
Sc-6412-3 (sn (b)(6)).The returned charger was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.The light emitting diode (led) of the charger turned green when it was fully recharged with the associated base station and power supply.The charger passed the functional test, and it was able to fully charge depleted known good implantable pulse generator (ipg) to 4.0vdc in four hours.The end of charge double beep was generated as expected.No anomalies were observed during the temperature test.The charging system exhibits normal characteristics.
Event or Problem Description
It was reported that the patient had a burn.The physician provided wound care to patient.

• 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 5798
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 22029144
• Report Number: 3006630150-2025-03384
• Device Sequence Number: 8112040
• Product Code: LGW
• UDI-Device Identifier: 08714729821243
• UDI-Public: (01)08714729821243(10)463803
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2025

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 Model Number: SC-6412-3
• Device Catalogue Number: SC-6412-3
• Device Lot Number: 463803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Female