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	Burn(s) (1757); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced burn at the ipg site while charging.The burned area was painful to touch and had a huge amount of swelling.The patient stated that the charger may have over heated.The patient applied ice and burn cream on the area as well as took an ibuprofen.
Additional Manufacturer Narrative
Date of event: exact date unknown, event occurred a week from the date the manufacturer became aware of the event.
Additional Manufacturer Narrative
The returned charger was analyzed, passed all tests performed, and exhibited normal device characteristics.
Event or Problem Description
It was reported that the patient experienced burn at the ipg site while charging.The burned area was painful to touch and had a huge amount of swelling.The patient stated that the charger may have over heated.The patient applied ice and burn cream on the area as well as took an ibuprofen.
Event or Problem Description
It was reported that the patient experienced burn at the ipg site while charging.The burned area was painful to touch and had a huge amount of swelling.The patient stated that the charger may have over heated.The patient applied ice and burn cream on the area as well as took an ibuprofen.

• 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: 16451137
• Report Number: 3006630150-2023-00896
• Device Sequence Number: 12116852
• Product Code: LGW
• UDI-Device Identifier: 08714729821243
• UDI-Public: (01)08714729821243(10)442427(21)442427
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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 Model Number: SC-6412-3
• Device Catalogue Number: SC-6412-3
• Device Lot Number: 442427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2023
• Supplement Date Received by Manufacturer: 05/04/2023; 06/05/2025
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 05/26/2023; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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: 23 YR
• Patient Sex: Male