Infinion 16Recalls & reported problems across all models

We found 5 models of Infinion 16 by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 1,550 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Sep 30, 2026 — classified as 15 deaths, 1,258 injuries, 277 malfunctions.

The most frequently reported specific device problem is “High impedance” (344 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Infinion 16 problems

Infinion 16 models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Infinion™ 16 SC-2316-50E

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  15 deaths978 reports
• Infinion™ 16 SC-2316-50

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  343 reports
• Infinion™ 16 SC-2316-70

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  149 reports
• Infinion™ 16 SC-2316-70E

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  79 reports
• Infinion™ 16 SC- 2316-50E

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 report

Recent Infinion 16 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High impedance; Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946744 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing pain. The patient had lead pull.

  Patient problems: Pain

  MAUDE report 50929784 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results

  It was reported that the patient had an inadequate stimulation and had a failed trial. The trial leads were discarded per hospital policy and patient was doing well.

  Patient problems: Pain

  MAUDE report 50910741 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that physician placed the first coude needle and lead, then while placing the second coude, the patient became unresponsive, she had no sedation on board. The physician pulled the coudes and lead. The patient was turned over onto a gurney and started to become responsive. The patient was taken to postop in stable condition. This incident was not device related. The trial leads will not be returned per hospital policy.

  Patient problems: Insufficient Information

  MAUDE report 50910667 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient went down after completing the trial procedure and what appeared to be a vasovagal response. Patient reported while on the table that she was not feeling well and was nauseous after placing the leads. Patient then passed out roughly for a minute and was provided with oxygen. Patient was responsive and was taken to the Emergency Department. The physician believed that it was not related to the device. The patient was doing well and the leads were pulled out.

  Patient problems: Nausea; Syncope/Fainting

  MAUDE report 50910655 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Neck Pain; Pain; Tissue Irritation

  MAUDE report 50906088 ↗
• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904254 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a trial procedure, the patient experienced excessive bleeding upon inserting the first needle. It was confirmed that the patient stopped taking blood thinners for seven days. The physician was not comfortable proceeding with the procedure, and it was aborted. The patient fully recovered after the procedure.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50898694 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was suspected of experiencing a cerebrospinal fluid (CSF) leak following the trial implant procedure. The patient was admitted to the emergency room (ER), where the leads were subsequently removed. The patient was recovering postoperatively.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 50860265 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results

  It was reported that patient failed her trial. The trial leads were discarded per hospital policy. No further information has been obtained despite good faith efforts.

  Patient problems: Pain

  MAUDE report 50850699 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection at the lead Incision site. Symptoms of redness and puss around the area of the leads were noted. The physician was not able to confirm if the infection was device or procedure related. The patient was administered antibiotics and underwent an explant procedure where the trial leads were removed. The patient was discharged from discharged from the hospital and will have a follow up appointment with infectious disease. The explanted trial leads were not returned as they were disposed of by the medical facility.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 50837582 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had trial procedure due to foot was broken as per her Emergency Room visit.

  Patient problems: Insufficient Information

  MAUDE report 50802707 ↗
• InjurySep 17, 2026Migration

  It was reported that one of the patient's trial leads came out. The patient underwent a procedure wherein the trial leads were removed and the patient was doing well postoperatively.

  Patient problems: Erosion

  MAUDE report 50801329 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had trial procedure physician noted CSF from the needle. The patient's oxygen saturation then began to decline into the 40s and procedure was aborted. Patient was transported to the emergency room via ambulance. Product was disposed of by the facility.

  Patient problems: Cerebrospinal Fluid Leakage; Hypoxia

  MAUDE report 50797889 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had lead pull.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797888 ↗

Other Boston Scientific Neuromodulation Corporation products

• Precision Spectra3 models · 11,348 reports
• Spectra WaveWriter4 models · 7,251 reports
• Precision17 models · 6,725 reports
• WaveWriter Alpha3 models · 4,356 reports · 1 recall
• Precision Montage MRI2 models · 4,332 reports
• Linear ST5 models · 4,068 reports
• Infinion CX2 models · 2,139 reports · 1 recall
• Superion5 models · 1,488 reports · 2 recalls