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 Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred few years prior to the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patients spinal cord stimulator (scs) paddle lead was cut during a non-confirmed device related procedure.The patient underwent a procedure wherein the paddle lead was replaced and the patient was doing well postoperatively.The explanted lead was retained by the medical facility and will not be returned.
Event or Problem Description
It was reported that the patients spinal cord stimulator (scs) paddle lead was cut during a non confirmed device related procedure.The patient underwent a procedure wherein the paddle lead was replaced and the patient was doing well postoperatively.The explanted lead was retained by the medical facility and will not be returned.
Additional Manufacturer Narrative
Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: the device was not returned for analysis, and the explanted paddle lead was retained by the medical facility.Although it was reported that the lead was cut during a non-confirmed device-related procedure, the complaint as reported could not be verified, and no additional information is available to definitively determine the circumstances surrounding the lead damage.Review of the device history record did not identify any manufacturing deviations that could have contributed to the event.Therefore, this investigation is unable to determine a definitive probable cause, and the conclusion code unable to exclude device problem is assigned.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23933092
• Report Number: 3006630150-2025-11810
• Device Sequence Number: 9473582
• Product Code: LGW
• UDI-Device Identifier: 08714729779919
• UDI-Public: (01)08714729779919(17)140201(10)15035436
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 03/19/2026

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 Expiration Date: 02/01/2014
• Device Model Number: SC-8216-70
• Device Catalogue Number: SC-8216-70
• Device Lot Number: 15035436
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 03/19/2026
• 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: 55 YR
• Patient Sex: Male