MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION LINEAR? 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2352-70
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Fall (1848); Device Overstimulation of Tissue (1991); Pain (1994)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: approximated based on the date the manufacturer became aware of the event - exact event date is unknown.Additional suspect medical device component involved in the event: model: sc-1416.Serial: (b)(6).Batch: (b)(6).Catalog description: wavewriter alpha prime 16 ipg kit.Udi: (b)(4).
Event or Problem Description
It was reported that the patient experienced shocking sensations in the abdomen when the device was turned on and off.It was noted that the patient's device was not functioning after a fall.The patient underwent a revision procedure where the ipg and lead were replaced.The patient was doing well post operatively.The explanted devices were not released by the medical facility and were not returned.
Event or Problem Description
It was reported that the patient experienced shocking sensations in the abdomen when the device was turned on and off.It was noted that the patient's device was not functioning after a fall.The patient underwent a revision procedure where the ipg and lead were replaced.The patient was doing well post operatively.The explanted devices were not released by the medical facility and were not returned.
Additional Manufacturer Narrative
Linear 3-4 lead 70 cm investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Wavewriter alpha prime 16 ipg kit investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.Block b3 date of event: approximated based on the date the manufacturer became aware of the event - exact event date is unknown.Additional suspect medical device component involved in the event: model: sc-1416 serial: (b)(6) batch: 211737 catalog description: wavewriter alpha prime 16 ipg kit udi: (b)(4).

• Brand Name: LINEAR? 3-4
• 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: 25053336
• Report Number: 3006630150-2026-02789
• Device Sequence Number: 13111483
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)250206(10)7076626
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 06/18/2026

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: 02/06/2025
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7076626
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 02/07/2023
• 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: 74 YR
• Patient Sex: Female