Infinion™ 16 SC-2316-50ERecalls & reported problems

Summary

The FDA's MAUDE database contains 978 adverse event reports that list this exact device (DI 08714729797807), received between Dec 8, 2016 and Sep 30, 2026 — classified as 15 deaths, 818 injuries, 145 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (96 reports).

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 978 reports, 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, 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

  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 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 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fecal Incontinence

  MAUDE report 50779979 ↗
• InjurySep 15, 2026Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779977 ↗
• InjuryAug 29, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50510198 ↗
• InjuryAug 18, 2026Nonstandard Device

  It was reported that the patient underwent trial procedure and lead was deemed damaged by the physician after removing it from the needle.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295712 ↗
• InjuryAug 18, 2026Migration

  It was reported that the leads migrated which was confirmed with imaging. The patient was experiencing bleeding was due to his high ibuprofen intake leading up to trial date. The patient was doing well, and explanted devices were not return.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50291923 ↗
• MalfunctionAug 17, 2026Nonstandard Device

  It was reported that the physician felt that the needle was too flexible and should not bend that easily.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50270980 ↗
• InjuryAug 12, 2026Positioning Problem

  It was reported that the patient experienced pain following the trial procedure. An early lead-pull procedure was subsequently performed; however, the pain persisted. Due to ongoing pain, the patient was admitted to the hospital for pain management and further evaluation. The physician indicated that the pain was not believed to be related to or caused by the device/equipment itself. Physician believes it was from advancing the leads and her baseline stenosis (poor anatomy). Nothing out of the ordinary occurred postoperatively. Unable to return the leads as they were retained and disposed of my facility per protocol.

  Patient problems: Pain

  MAUDE report 50225910 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following a trial procedure, the patient became confused, removed the tape securing the trial leads, and pulled out the leads because they were uncomfortable. The removed leads were not returned as they were disposed of at the physicians office. The patient was reported to be doing well and was scheduled to undergo a repeat trial.

  Patient problems: Discomfort

  MAUDE report 50155138 ↗
• InjuryAug 5, 2026Positioning Problem

  It was reported that the physician was not able to access the patient's epidural space during a trial procedure. The trial procedure was aborted and the patient loss consciousness when getting up after the procedure.

  Patient problems: Loss of consciousness; Syncope/Fainting

  MAUDE report 50142390 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a new pain in the right ribs during a Spinal Cord Stimulator (SCS) trial. The physician confirmed that the nerve got irrigated during the trial procedure and determined this to be the cause of the pain. As a result, the patient underwent an early lead pull procedure, and the pain reportedly improved within a few days. The explanted devices were not returned as they were disposed of by the medical facility.

  Patient problems: Pain

  MAUDE report 50134744 ↗
• MalfunctionJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50106419 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a trial procedure, the physician successfully entered the epidural space through the T12 and T11 interspace using standard Tuohy needle that is a part of the Infinion trial kit. The patient complained of extreme discomfort upon physician advancing the lead. Posterior lead placement was confirmed under fluoroscopy. Physician then attempted to advance the lead through alternative trajectory and aborted after patient complained of extreme discomfort once again. The lead was discarded.

  Patient problems: Discomfort

  MAUDE report 50101569 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following a spinal cord stimulation (SCS) trial procedure, the patient developed a urinary tract infection. The infection progressed to septic shock, and the patient was reported to have been at risk of death. As a result, the patient was hospitalized and remained in the intensive care unit (ICU) for 15 days. Following discharge from the hospital, the patient was admitted to a nursing home for rehabilitation therapy. The patient was reported to be unable to walk and to have impaired vision.

  Patient problems: Ambulation or Postural Difficulties; Loss of Vision; Paralysis; Septic Shock; Urinary Tract Infection

  MAUDE report 50085903 ↗
• InjuryJul 27, 2026Positioning Problem

  it was reported that the patient was experiencing nerve root irritation. The patient was given steroid. Patient new pain was resolving but still there.

  Patient problems: Pain; Tissue Irritation

  MAUDE report 50037847 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was sent to the Emergency Department due to shortness of breath. The trial leads were pulled out and discarded per hospital policy. It was then determined that the patient was actually taking antibiotics for a current pneumonia infection he had prior to the trial. The patient was doing well postoperatively.

  Patient problems: Dyspnea

  MAUDE report 50031974 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.