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

Model Number	SC-2218-50E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Confusion/ Disorientation (2553)
Date of Event	08/14/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that during the implant of the trial leads of the spinal cord stimulator (scs), for which the patient was under sedation, it was noted that a cerebrospinal fluid (csf) leak may have occurred.Once the procedure was completed and the patient was turned over the patient was not coherent and not responsive.The patient was transported to a hospital, and it was later reported that the patient passed away at the hospital.No additional information has been received.
Event or Problem Description
It was reported that during the implant of the trial leads of the spinal cord stimulator (scs), for which the patient was under sedation, it was noted that a cerebrospinal fluid (csf) leak may have occurred.Once the procedure was completed and the patient was turned over the patient was not coherent and not responsive.The patient was transported to a hospital, and it was later reported that the patient passed away at the hospital.No additional information has been received.

• Brand Name: LINEAR ST
• 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: 20173168
• Report Number: 3006630150-2024-05982
• Device Sequence Number: 8070328
• Product Code: LGW
• UDI-Device Identifier: 08714729784067
• UDI-Public: 08714729784067
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2024

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: 01/22/2026
• Device Model Number: SC-2218-50E
• Device Catalogue Number: SC-2218-50E
• Device Lot Number: 7140561
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/24/2024
• Date Device Manufactured: 01/23/2024
• 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: Death
• Patient Age: 72 YR
• Patient Sex: Female