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 Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: wavewriter alpha? prime 16 upn: m365sc14160 model: sc-1416 serial: (b)(6).Batch: 208710 udi: (b)(4).
Event or Problem Description
It was reported that the patient had a non-device-related fall and two weeks later experienced less effective stimulation.It was then found during a check-up that the lead displayed multiple high impedances, and the ipg displayed the elective replacement indicator (eri) message.The physician suspected that the high impedances may have resulted in the eri.The patient underwent a lead and ipg replacement procedure and was doing well postoperatively.
Event or Problem Description
It was reported that the patient had a non-device-related fall and two weeks later experienced less effective stimulation.It was then found during a check-up that the lead displayed multiple high impedances, and the ipg displayed the elective replacement indicator (eri) message.The physician suspected that the high impedances may have resulted in the eri.The patient underwent a lead and ipg replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: brand name: wavewriter alpha? prime 16.Model: sc-1416.Serial: (b)(6).Batch: 208710.Udi: (b)(4).Brand name: clik? x.Model: sc-4318.Serial: n/a.Batch: 28504931.Udi: (b)(4).The allegations of high impedances and inadequate stimulation were confirmed.With the available information, boston scientific concludes that inadequate stimulation and high impedances were caused by a lead fracture identified during laboratory analysis where the lead body exited the clik x anchor.Lead sc-2352-70 sn: (b)(6): visual and x-ray inspection of the returned lead revealed that multiple cables were completely broken at the bent location of the lead.The bent location is near the set screw mark of the clik x anchor.The possible flexing of the lead at the exit point of the clik x anchor has resulted in the reported complaint.Additionally, inspection identified that the lead had been cleanly cut into two sections near the distal end.The first contact on the proximal segment was removed and not present.The contact was confirmed to have been explanted from the patient.No blood or bodily fluid residue was observed at the proximal tip, indicating that the damage most likely occurred during the explant procedure.The clean cut is consistent with standard explant techniques and is not considered a device failure.Electrical testing could not be performed due to the severed lead body.Ipg sc-1416 sn: (b)(6): the returned ipg has been confirmed to be in the elective replacement indicator (eri) state.Analysis of the data log shows that the ipg reached eri 3 years, 8 months, after the initial active programming.The average energyuse index (eui) recorded was 14.3, which corresponds to an estimated theoretical battery lifespan of 2 years, 1 months, and 26.4 days.This indicates that the battery lifespan fell within the projected range.Clik anchor sc-4318 lot 28504931: the returned clik x anchor was analyzed and exhibited normal device characteristics.The associated record lead was tested with the clik x anchor, and the setscrew successfully secured the lead body without issue.A review of the device history record (dhr) was performed for the devices.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A labeling review for the lead, ipg and clik anchor did not reveal any anomalies.The instructions for use (ifu) states that system failure, can occur at any time due to random failures of the components.These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control, all of which are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.Additionally, when the stimulator battery is fully depleted, the end of service (eos) indicator will be displayed on the remote control and clinician programmer.Stimulation will not be available.Surgery is required to replace the implanted non-rechargeable stimulator to continue providing stimulation.A review of the wavewriter alpha prime 16 ipg kit hazard analysis was completed and confirmed that the event of stimulation inadequate was defined in the risk documentation.This event type has been accounted for during product risk analysis to support an acceptable risk-benefit for the product.Based on all available information, engineers concluded that the inadequate stimulation and high impedance measurements were caused by a lead fracture.The leads became bent after exiting the clik x anchor, which exposed the bent location to excessive mechanical force or movement that caused the lead cables to fracture due to component failure.

• 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: 24047721
• Report Number: 3006630150-2026-00294
• Device Sequence Number: 13188554
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)240210(10)7073793
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/05/2026

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: 02/10/2024
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7073793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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 Sex: Unknown