Infinion™ 16 SC-2316-70ERecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 08714729837145), received between May 11, 2018 and Sep 28, 2026 — classified as 70 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (9 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 79 reports, in the reporter's own words as published by the FDA.

• 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 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Neck Pain; Pain; Tissue Irritation

  MAUDE report 50906088 ↗
• 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 ↗
• InjuryAug 5, 2026Device Fell

  It was reported that the patient had trial procedure due to lead dropped from Sterile field during procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50143040 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PINCHING PAIN FOLLOWING A TRIAL PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION AND WAS PRESCRIBED WITH MEDICATION. THE PATIENT'S TRIAL LEADS WERE EXPLANTED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 25638412 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED EXPERIENCING PROGRESSIVELY WORSENING HEADACHES DURING THE TRIAL PROCEDURE. DOSE ADJUSTMENTS AND PROGRAM OPTIMIZATION WERE ATTEMPTED; HOWEVER, THESE INTERVENTIONS WERE UNSUCCESSFUL IN ALLEVIATING THE SYMPTOMS. AS A RESULT, A LEAD REMOVAL PROCEDURE WAS PERFORMED.

  Patient problems: Headache; Inappropriate Device Stimulation of Tissue

  MAUDE report 25524939 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTLY AFTER A TRIAL PROCEDURE WHEREIN THE PATIENT WAS INTUBATED DURING THE TRIAL, THE PATIENT WAS SENT TO THE EMERGENCY ROOM DUE TO CHEST PAIN AND SHORTNESS OF BREATH AND PATIENT'S BLOOD PRESSURE SPIKED. THE PHYSICIAN UNPLUGGED THE DEVICE AND PATIENTS BLOOD PRESSURE RETURNED TO NORMAL LEVELS. THE CAUSE WAS UNKNOWN. WHEN THEY GOT THE SCANS BACK, EVERYTHING WAS NORMAL. THE TRIAL LEADS WERE PULLED OUT AND WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Chest Pain; Dyspnea; High Blood Pressure/ Hypertension

  MAUDE report 25523836 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL DUE TO INCREASED PAIN AT THE LEAD INCISION SITE FOLLOWING A TRIAL PROCEDURE. THE PATIENT'S OXYGEN LEVELS DECREASED WHILE IN THE HOSPITAL AND WAS ADMITTED TO THE ICU (INTENSIVE CARE UNIT). THE PATIENT STATUS WAS STABLE AND HAD BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Hypoxia; Pain

  MAUDE report 25253797 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TRIAL PROCEDURE AND THE PATIENT'S HEART RATE DROPPED WHEN THE IMPEDANCE OF THE TRIAL LEADS WERE CHECKED. IT WAS ALSO STATED THAT THE PATIENT WAS HAVING DIFFICULTY HEARING. THE PHYSICIAN BELIEVED THAT THE INCIDENT WAS NOT DEVICE RELATED AND THE PATIENT NERVOUS AND WAS HAVING JAW PAIN BEFOREHAND. THE PHYSICIAN DECIDED TO EXPLANT THE TRIAL LEADS AND THE EXPLANTED DEVICES WERE DISPOSED AND WILL NOT BE RETURNED.

  Patient problems: Bradycardia

  MAUDE report 25055824 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EXTREME POSITIONAL HEADACHE DURING A TRIAL PROCEDURE. THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD A CSF (CEREBROSPINAL FLUID) LEAK AND WAS ADMINISTERED WITH BLOOD PATCH. THE WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 24996670 ↗
• InjuryMar 13, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DURING THE TRIAL PROCEDURE PERIOD. DURING SPINAL CORD STIMULATION (SCS) LEAD PULL AN X-RAY REVEALED THE LEADS HAD MIGRATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595128 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SIGNIFICANT RASH DUE TO THE ADHESIVE OF THE TAPE AND DEVELOPED AN IMPETIGO AROUND THE INCISION SITE. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM AND WAS TREATED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Bacterial Infection; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 24458921 ↗
• InjuryFeb 18, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE INTERMITTENT STIMULATION DUE TO SPINAL CORD STIMULATOR (SCS) TRIAL LEADS HAD MIGRATED. X-RAY IMAGING CONFIRMED DEVICE MIGRATION. THE PATIENT UNDERWENT A SCS TRIAL LEAD EXPLANT. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Pain

  MAUDE report 24381405 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE PATIENT EXPERIENCED PAIN. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURN.

  Patient problems: Pain

  MAUDE report 24200211 ↗
• InjuryJan 16, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT WHILE UNDERGOING TRIAL THE PATIENT WAS EXPERIENCING RIB STIMULATION AT END OF TRIAL AND NOTICED THAT ONE OF THE CABLES WAS DISCONNECTED. THE PATIENT WAS ALSO EXPERIENCING RASH FROM THE TAPE. THE PATIENT COMPLETED THE TRIAL PROCEDURE.

  Patient problems: Pain; Rash

  MAUDE report 24093176 ↗
• InjuryJan 12, 2026Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT A LEAD LEAD PULL PROCEDURE.

  Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation

  MAUDE report 24039978 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TRIAL PROCEDURE WAS ABORTED DUE TO PATIENT HAVING AN ANESTHESIA COMPLICATION. THE TRIAL LEADS WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Insufficient Information

  MAUDE report 23987250 ↗
• InjuryJan 5, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING TRIAL WHEN THE LEAD MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959959 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART ARRHYTHMIA FOLLOWING THE TRIAL PROCEDURE. THE PHYSICIAN BELIEVED THAT IT WAS NEITHER DEVICE NOR PROCEDURE RELATED. THE PATIENT HAD ENDED UP IN THE INTENSIVE CARE UNIT (ICU), AND THE LEADS WERE REMOVED AND DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Arrhythmia

  MAUDE report 23635714 ↗
• InjuryNov 5, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) TRIAL LEAD REMOVAL PROCEDURE DUE TO EXPERIENCING SHOCKING SENSATIONS. NO ADDITIONAL INFORMATION WAS RECEIVED DESPITE MULTIPLE GOOD FAITH EFFORTS.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 23479792 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE TESTICULAR REGION AND HAD A HARD TIME URINATING EVEN THOUGH HIS BLADDER WAS FULL. THE PHYSICIAN PRESCRIBED VICODIN; HOWEVER, THE PAIN PERSISTED. IT WAS UNKNOWN IF THE SAID SYMPTOMS WERE DEVICE RELATED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 23353949 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CEREBROSPINAL FLUID LEAK DURING THE TRIAL LEAD IMPLANT PROCEDURE. THE PHYSICIAN ABORTED THE PROCEDURE AND THE DEVICE WAS DISPOSED BY THE FACILITY. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 22928081 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL PROCEDURE A NERVE WAS TWEAKED THAT CAUSED INCREASE PAIN. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22784939 ↗
• InjuryJul 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING DISCOMFORT IN THE LEGS. THE PATIENT UNDERWENT A LEAD PULL PROCEDURE AND THE LEAD WAS KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS THEN SENT TO THE EMERGENCY ROOM (ER). MAGNETIC RESONANCE IMAGING (MRI) WAS DONE AND SHOWED THAT THE PATIENT HAD AN EPIDURAL ABSCESS. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS ADMINISTERED WITH ANTIBIOTICS. UPON FOLLOW-UP, THE PATIENT HAD BEEN DISCHARGED AND WAS DOING WELL.

  Patient problems: Abscess; Discomfort

  MAUDE report 22551559 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO A DRUG ADMINISTERED TOWARDS THE END OF THE TRIAL PROCEDURE, THE PATIENTS HEART RATE STARTED TO CRASH. PHYSICIAN HAD TO ADMINISTER CARDIOPULMONARY RESUSCITATION TO PATIENT. THE PATIENT WAS THEN SENT TO THE HOSPITAL AND THE TRIAL LEADS ENDED UP GETTING PULLED OUT AND DISCARDED PER HOSPITAL POLICY. THE PATIENT IS CURRENTLY DOING BETTER AND THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED.

  Patient problems: Insufficient Information

  MAUDE report 22543391 ↗

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-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-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-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-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-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.