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

Model Number	SC-8216-70
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Pain (1994); Seroma (2069); Swelling/ Edema (4577)
Date of Event	06/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of pain, swelling and hot to touch in the cervical area.The patient was admitted to the hospital and was provided with intravenous (iv) antibiotics.It was also noted that the patient had seroma and was drained.Imaging results showed that spinal cord stimulator (scs) paddle had migrated.The patient was doing well and no further action was needed.The devices remained implanted and in service.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model number/catalog number: sc-1232 serial number: (b)(6) batch/lot number: 824091 model/catalog description: wavewriter alpha 32 ipg kit unique identifier (udi)#: (b)(4).

• Brand Name: ARTISAN?
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25767195
• Report Number: 3006630150-2026-04808
• Device Sequence Number: 9898927
• Product Code: LGW
• UDI-Device Identifier: 08714729779919
• UDI-Public: (01)08714729779919(17)280218(10)7078861
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/09/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-8216-70
• Device Catalogue Number: SC-8216-70
• Device Lot Number: 7078861
• 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: 06/14/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 02/18/2026
• 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: 30 YR
• Patient Sex: Female