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

Model Number	SC-8416-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a spinal cord stimulator (scs) implant procedure, the patient experienced a suspected loss of motor function in the lower extremity.The suspected or known cause of the neurological symptoms is unknown.It is unknown if the physician believes that the event was device related.Nothing happened during the scs implant procedure that may have caused or contributed to the event.The patient underwent a procedure where the scs system was explanted.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 763263.

• Brand Name: ARTISAN MRI
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 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: 20208053
• Report Number: 3006630150-2024-06051
• Device Sequence Number: 6815913
• Product Code: LGW
• UDI-Device Identifier: 08714729951131
• UDI-Public: 08714729951131
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/12/2024

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: 06/27/2026
• Device Model Number: SC-8416-70
• Device Catalogue Number: SC-8416-70
• Device Lot Number: 7076318
• 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: 08/17/2024
• Initial Report FDA Received Date: 09/12/2024
• Date Device Manufactured: 06/27/2024
• 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: 66 YR
• Patient Sex: Female