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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	04/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field d2b pro code (product code): qrb.Additional suspect medical device components involved in the event: brand name: infinion pro, upn: m365sc2318700, model: sc-2318-70, serial: (b)(6), batch: 5008801, udi# (b)(4).Brand name: wavewriter alpha ipg kit, upn: m365sc12320, model: sc-1232, serial: (b)(6), batch: 798383, udi# (b)(4).Brand name: clik x, upn: m365sc43180, model: sc-4318, serial: n/a, batch: 36495273, udi# (b)(4).
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient developed an infection at the anchor site.The patient had symptoms of redness, swelling, tenderness, and a temperature.There were no device issues, however, the patient underwent an explant procedure to have all devices explanted.The patient was also treated with antibiotics.At the post-op wound review, there were no signs of infection and the patient was healing as expected with no further complications.A culture was performed but results were not provided.The physician stated that it was most likely a superficial infection from the incision.All explanted devices were discarded by the medical facility.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient developed an infection at the anchor site.The patient had symptoms of redness, swelling, tenderness, and a temperature.There were no device issues, however, the patient underwent an explant procedure to have all devices explanted.The patient was also treated with antibiotics.At the post-op wound review, there were no signs of infection and the patient was healing as expected with no further complications.A culture was performed but results were not provided.The physician stated that it was most likely a superficial infection from the incision.All explanted devices were discarded by the medical facility.Additional information was received that cultures were taken and it was indicative of a skin infection.However, the physician assessed that the infection was not related to any of the devices but rather something the patient managed to pick up.
Additional Manufacturer Narrative
Field d2b pro code (product code): qrb.Additional suspect medical device components involved in the event: brand name: infinion pro.Upn: m365sc2318700.Model: sc-2318-70.Serial: (b)(6).Batch: 5008801.Udi# (b)(4).Brand name: wavewriter alpha ipg kit.Upn: m365sc12320.Model: sc-1232.Serial: (b)(6).Batch: 798383.Udi# (b)(4).Brand name: clik x.Upn: m365sc43180.Model: sc-4318.Serial: n/a.Batch: 36495273.Udi# (b)(4).The devices were not returned for analysis and the event of the patient having an infection at the wound site was not able to be confirmed.A review of the device history record (dhr) confirmed that the devices met specification prior to shipping.A labeling review did not reveal any anomalies as it states that possible surgical procedural risks are temporary pain at the implant site, infection, cerebrospinal fluid (csf) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis and tissue reaction to implanted materials can occur are known risks with the use of spinal cord stimulation (scs).The devices were not returned for analysis, which limited the ability to conduct a comprehensive evaluation.A review of the device history record confirmed that the devices met all manufacturing specifications prior to distribution.The reported symptoms of fever, swelling, and redness are consistent with an infection; however, based on the available information, including the physician's assessment, these symptoms were attributed to the infection itself and not to a device-related issue.Although infection is a known risk associated with surgical procedures involving spinal cord stimulation (scs) systems, the evidence does not support a direct causal relationship with the devices.Therefore, a definitive root cause could not be determined, and this event was assigned a conclusion code of cause not established.

• 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: 25089322
• Report Number: 3006630150-2026-02917
• Device Sequence Number: 5005017
• Product Code: LGW
• UDI-Device Identifier: 00191506018733
• UDI-Public: (01)00191506018733(17)280127(10)5008784
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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 Model Number: SC-2318-70
• Device Catalogue Number: SC-2318-70
• Device Lot Number: 5008784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 01/27/2026
• 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: 42 YR
• Patient Sex: Male