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

Model Number	SC-2317-50
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in the year of 2023.Block d2b: pro code (product code): qrb.Block d6b: explant date: 2023.Additional suspect medical device components involved in the event: model number/catalog number: sc-1232.Serial number: (b)(6).Batch/lot number: (b)(6).Model/catalog description: wavewriter alpha 32 ipg kit.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-2317-50.Serial number: (b)(6).Batch/lot number: 19853544.Model/catalog description: infinion cx lead kit, 50cm.Unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that the patient had multiple surgeries for loose wires, leads detaching and implantable pulse generator (ipg) being loose.It was noted that the patient was tired of being cut open to replace things.It was also reported that the patient experienced inadequate pain relief.The patient subsequently underwent a spinal cord stimulator (scs) system explant procedure.
Event or Problem Description
It was reported that the patient had multiple surgeries for loose wires, leads detaching and implantable pulse generator (ipg) being loose.It was noted that the patient was tired of being cut open to replace things.It was also reported that the patient experienced inadequate pain relief.The patient subsequently underwent a spinal cord stimulator (scs) system explant procedure.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in the year of 2023.Block d2b: pro code (product code): qrb.Block d6b: explant date: 2023.Additional suspect medical device components involved in the event: model number/catalog number: sc-1232 serial number: (b)(6) batch/lot number: 516096 model/catalog description: wavewriter alpha 32 ipg kit unique identifier (udi) #: (b)(4) model number/catalog number: sc-2317-50 serial number: (b)(6) batch/lot number: 19853544 model/catalog description: infinion cx lead kit, 50cm unique identifier (udi) #: (b)(4).Investigation results: the devices were not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed these devices 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.

• Brand Name: INFINION? CX
• 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: 25265024
• Report Number: 3006630150-2026-03426
• Device Sequence Number: 9759010
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: (01)08714729861614(17)181018(10)19853544
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 06/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/18/2018
• Device Model Number: SC-2317-50
• Device Catalogue Number: SC-2317-50
• Device Lot Number: 19853544
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/23/2026
• Supplement Report FDA Received Date: 06/19/2026
• Date Device Manufactured: 10/18/2016
• 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: 48 YR
• Patient Sex: Female