MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION Infinion? Pro; stimulator, spinal-cord, totally implanted for pain relief

Model Number	SC-2318-70
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was not feeling any relief and leads had impedances and migrated.The patient underwent lead repositioning procedure.Patient was doing great postoperatively.
Additional Manufacturer Narrative
Block d2b: qrb.Additional suspect medical device component involved in the event: model number/catalog number: sc-2318-70 serial number: (b)(6) batch/lot number: 5008311 model/catalog description: infinion pro lead kit, 16 contact, 70cm unique identifier (udi) #:(b)(4).Sc-2318-70 (sn (b)(6)).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed that the device met specifications prior to shipping.Labeling review: a labeling review did not reveal any anomalies as it states: lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief and system failure, which can occur at any time due to random failure(s) 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 are known risks with the use of spinal cord stimulation (scs).Sc-2318-70 (sn(b)(6)).Investigation result: the device was not returned to boston scientific for analysis.Device history record: a review of the device history record (dhr) confirmed that the device met specifications prior to shipping.Labeling review: a labeling review did not reveal any anomalies as it states: lead migration, resulting in undesirable changes in stimulation and subsequent reduction in pain relief, 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 and persistent pain at the ipg or lead site are known risks with the use of spinal cord stimulation (scs).Investigation conclusion: based on a thorough review of the reported complaint, an investigation conclusion code of cause not established was assigned to the investigation for all components.

• Brand Name: Infinion? Pro
• 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; PR 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; +1(763)292-0920
• MDR Report Key: 50311695
• Report Number: 3006630150-2026-06030
• Device Sequence Number: 21516697
• Product Code: LGW
• UDI-Device Identifier: 00191506018733
• UDI-Public: (01)00191506018733(17)271222(10)5008410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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 Model Number: SC-2318-70
• Device Catalogue Number: SC-2318-70
• Device Lot Number: 5008410
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 12/22/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 290 LB