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
Event or Problem Description
It was reported that the patient experienced a non-device related severe slipping movement with a severe twist in his body.Over time, the pain-relieving effect of his scs implant diminished, and all lead impedances were found to be elevated.The patient underwent a lead replacement procedure and regained pain relief postoperatively.
Additional Manufacturer Narrative
The returned lead was analyzed and x-ray inspection revealed that all 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.There are no exposed cables at the fracture location.The lead was kinked after it exits the clik x anchor resulting in the reported complaint.A review of the device history record (dhr) was performed.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 product labeling review did not reveal any anomalies as it states that system failure, can occur at any time due to random failure of the components or the battery.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.Additionally, undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and or lead failure, all of which are known risks associated with implanting a pulse generator as part of a spinal cord stimulation system.A review of the linear 3-4 lead 70 cm hazard analysis was completed and confirmed that the event of migration was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The event was confirmed.Visual and x-ray inspection of the returned lead revealed that all 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.There are no exposed cables at the bent location of the lead.The possible flexing of the lead at the exit point of the clik x anchor has resulted in the reported fracture and is traced to component failure.
Event or Problem Description
It was reported that the patient experienced a severe slipping movement with a severe twist in his body.Over time, the pain-relieving effect of his scs implant diminished, and all lead impedances were found to be elevated.The patient underwent a lead replacement procedure and regained pain relief postoperatively.
Event or Problem Description
It was reported that the patient experienced a severe slipping movement with a severe twist in his body.Over time, the pain relieving effect of his scs implant diminished, and all lead impedances were found to be elevated.The patient underwent a lead replacement procedure and regained pain relief postoperatively.
Additional Manufacturer Narrative
Correction to the supplemental 1 mdr in section h11: review of the hazard analysis should have stated inadequate stimulation (not migration).The returned lead was analyzed and x-ray inspection revealed that all 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.There are no exposed cables at the fracture location.The lead was kinked after it exits the clik x anchor resulting in the reported complaint.A review of the device history record (dhr) was performed.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 product labeling review did not reveal any anomalies as it states that system failure, can occur at any time due to random failure of the components or the battery.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.Additionally, undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and or lead failure, all of which are known risks associated with implanting a pulse generator as part of a spinal cord stimulation system.A review of the linear 3-4 lead 70 cm hazard analysis was completed and confirmed that the event of inadequate stimulation was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The event was confirmed.Visual and x-ray inspection of the returned lead revealed that all 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.There are no exposed cables at the bent location of the lead.The possible flexing of the lead at the exit point of the clik x anchor has resulted in the reported fracture and is traced 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: 24310829
• Report Number: 3006630150-2026-00827
• Device Sequence Number: 4837556
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: (01)08714729789581(17)251003(10)7079001
• 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: 2024
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 04/21/2026

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: 10/03/2025
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 7079001
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 04/21/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/20/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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 Sex: Unknown