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

Model Number	SC-2366-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Defective Device (2588); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced loss of pain coverage.The patient fell onto her back and subsequently the cluneal spinal cord stimulation leads migrated.The physician stated that the lead appeared to be fractured, however there was no x-ray imaging performed.The patient underwent a revision procedure in which the leads were replaced.There were no patient complications, and the patient was doing well postoperatively.The explanted leads will not be returned as they were discarded at the medical facility.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event brand name linear 3-6 upn m365sc2366500 model sc-2366-50 serial (b)(6).Batch (b)(6).

• Brand Name: LINEAR 3-6
• 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: 20645860
• Report Number: 3006630150-2024-07706
• Device Sequence Number: 15314158
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: 08714729789574
• 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: 2020
• Device Explanted Year: 2024
• 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): 11/08/2024

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: 10/08/2021
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 3138408
• 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: 10/20/2024
• Initial Report FDA Received Date: 11/08/2024
• Date Device Manufactured: 02/20/2017
• 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: 54 YR
• Patient Sex: Female