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	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the patients' lead of the spinal cord stimulator (scs) system migrated causing the patient to experience inadequate stimulation.Imaging was performed which confirmed lead migration.The patient underwent a procedure in which one of the four implanted leads was explanted and replaced with a new lead, and two of the leads were repositioned.The patient is doing well post operatively.The explanted lead will not be returned as it was disposed of by the facility, and the remaining devices remain implanted and in service.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: brand name: linear 3-6.Upn: m365sc2366700.Model: sc-2366-70.Serial: (b)(6).Batch: 7071194.Brand name: linear 3-6.Upn: m365sc2366700.Model: sc-2366-70.Serial: (b)(6).Batch: 7070520.Brand name: linear 3-6.Upn: m365sc2366700.Model: sc-2366-70.Serial: (b)(6).Batch: 7070887.

• 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: 19953110
• Report Number: 3006630150-2024-05234
• Device Sequence Number: 15688835
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 10/03/2021
• Device Model Number: SC-2366-70
• Device Catalogue Number: SC-2366-70
• Device Lot Number: 7070103
• 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: 07/19/2024
• Initial Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 10/04/2019
• 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: 72 YR
• Patient Sex: Female