MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-6; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2366-70
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: linear 3-6.Upn: m365sc2366700.Model: sc-2366-70.Serial: (b)(6).Batch: 7074626.Brand name: linear 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 7078180.Brand name: linear 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 7079377.
Event or Problem Description
It was reported that the patient experienced a motor vehicle accident and subsequently the spinal cord stimulation (scs) leads migrated.In addition, one of the patients leads displayed high impedances, although it is uncertain when this impedance first presented.The patient underwent a revision procedure in which the leads were repositioned.No devices were implanted or explanted.It was noted that postoperatively the high impedances remained, and it is uncertain if it impacted the patients therapy.No further information can be obtained.The patient was doing well postoperatively.

• Brand Name: LINEAR 3-6
• 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: 20185961
• Report Number: 3006630150-2024-06020
• Device Sequence Number: 15544720
• Product Code: LGW
• UDI-Device Identifier: 08714729789567
• UDI-Public: 08714729789567
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2025
• Device Model Number: SC-2366-70
• Device Catalogue Number: SC-2366-70
• Device Lot Number: 7074799
• 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: 08/16/2024
• Initial Report FDA Received Date: 09/10/2024
• Date Device Manufactured: 04/02/2023
• 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: 47 YR
• Patient Sex: Female