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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Muscle Weakness/Atrophy (1967); Pain (1994)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced left lower extremity weakness and severe pain following a trial procedure.The physician noticed that the patient was leaking cerebrospinal fluid after the leads were successfully placed.The patient underwent a lead pull procedure and was given steroids.The explanted leads were not returned as they were discarded by the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads upn: m365sc221850e0 model: sc-2218-50e serial: (b)(6).Batch: (b)(6).

• 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: 20534478
• Report Number: 3006630150-2024-07328
• Device Sequence Number: 18213787
• Product Code: LGW
• UDI-Device Identifier: 08714729784067
• UDI-Public: 08714729784067
• 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: 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): 10/25/2024

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: 08/25/2026
• Device Model Number: SC-2218-50E
• Device Catalogue Number: SC-2218-50E
• Device Lot Number: 7151628
• 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: 10/04/2024
• Initial Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 08/25/2024
• 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: 80 YR
• Patient Sex: Male