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 Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date approximate.Additional suspect medical device components involved in the event: brand name: linear 3-6 upn: m365sc2366500 model: sc-2366-50 serial: (b)(6) batch: 17674699 udi: (b)(4).Brand name: linear 3-6 upn: m365sc2366500 model: sc-2366-50 serial: (b)(6) batch: 17634074 udi: (b)(4).Brand name: precision spectra upn: m365sc11320 model: sc-1132 serial: (b)(6) batch: 18462109 udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced an uncomfortable spiky sensation in her back.The patient underwent a procedure in which the entire spinal cord stimulation (scs) system was explanted.The patient was doing well postoperatively.The explanted devices will not be returned as they were retained by the medical facility.
Event or Problem Description
It was reported that the patient experienced an uncomfortable spikey sensation in her back.The patient underwent a procedure in which the entire spinal cord stimulation (scs) system was explanted.The patient was doing well postoperatively.The explanted devices will not be returned as they were retained by the medical facility.
Additional Manufacturer Narrative
Block b3: date approximate additional suspect medical device components involved in the event: brand name: linear 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 17674699.Udi: (b)(4).Brand name: linear 3-6.Upn: m365sc2366500.Model: sc-2366-50.Serial: (b)(6).Batch: 17634074.Udi: (b)(4).Brand name: precision spectra.Upn: m365sc11320.Model: sc-1132.Serial: (b)(6).Batch: 18462109.Udi: (b)(4).

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 21852048
• Report Number: 3006630150-2025-02533
• Device Sequence Number: 8817657
• Product Code: LGW
• UDI-Device Identifier: 08714729789574
• UDI-Public: (01)08714729789574(17)170531(10)17942007
• 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: 2015
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/21/2025

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: 05/31/2017
• Device Model Number: SC-2366-50
• Device Catalogue Number: SC-2366-50
• Device Lot Number: 17942007
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 04/19/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 04/21/2025
• Date Device Manufactured: 05/11/2015
• 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: 49 YR
• Patient Sex: Female