Artisan™ MRI SC-8416-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 08714729951131), received between Dec 29, 2017 and Sep 23, 2026 — classified as 82 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (36 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a staged trial while trying to access the cervical space, the patient lost some sensory function to right side of body, and the physician decided it was best to abort the case. No product was implanted. The lead will not be returned per hospital policy. No further information has been obtained despite good faith efforts.

  Patient problems: Insufficient Information

  MAUDE report 50864886 ↗
• InjuryJul 20, 2026Off-Label Use

  IT WAS REPORTED THAT FOLLOWING A CERVICAL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS AND TINGLING IN THE UPPER AND LOWER EXTREMITIES. THE PHYSICIAN SUSPECTED HEMATOMA. THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM AND UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.

  Patient problems: Hematoma; Numbness; Paresthesia

  MAUDE report 25874099 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE LOWER EXTREMITY PARALYSIS. THE PATIENT HAD MAGNETIC RESONANCE IMAGING (MRI) PERFORMED THAT SHOWED BLEEDING AND THE PATIENT UNDERWENT EMERGENCY SURGERY TO EVACUATE A HEMATOMA ASSOCIATED WITH THE SCS PLACEMENT. THE EVENT WAS RELATED TO AN UNKNOWN BLOOD DISORDER. IT WAS NOTED THAT THE PATIENT WAS CURRENTLY IN STABLE CONDITION.

  Patient problems: Hematoma; Paralysis

  MAUDE report 24783580 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED NODULES AND INFLAMMATION AROUND THE NECK DUE TO A NICKEL ALLERGY ON ONE OF THE IMPLANTED LEADS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 24553511 ↗
• InjuryMar 9, 2026High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED PER HOSPITAL POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542733 ↗
• InjuryNov 4, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED, AND TWO NEW LEADS WERE ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23461864 ↗
• InjuryJul 18, 2025High impedance; Charging Problem; High impedance; Charging Problem

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD HIGH IMPEDANCES. IT WAS ALSO REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543753 ↗
• InjuryMay 30, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED TO BETTER COVER THE LEFT SIDE OF PAIN. THE LEAD REMAINS IMPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 22114725 ↗
• InjuryMay 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082709 ↗
• InjuryMar 24, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO INADEQUATE STIMULATION CAUSING CHRONIC LOW BACK PAIN TO THE PATIENT, THIS WAS LINKED TO THE LEAD PLACEMENT AT THORACIC T9-T10. ALTHOUGH THE EXACT CAUSE REMAINS UNKNOWN, IT IS SUSPECTED THAT THE INITIAL PLACEMENT MAY HAVE CONTRIBUTED TO THE PROBLEM. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THEIR LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS DOING WELL POST OPERATIVELY AND ADEQUATE STIMULATION HAS BEEN ACHIEVED. THE DEVICE WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Pain

  MAUDE report 21676500 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PADDLE LEAD EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510180 ↗
• InjuryDec 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) LEAD REVISION DUE TO AN UNKNOWN REASON. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032102 ↗
• InjuryDec 3, 2024High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO PRESENCE OF CERVICAL PADDLE IMPEDANCES AND THE PATIENT WANTED MAGNETIC RESONANCE IMAGING (MRI). THE PATIENT IS DOING WELL POST OPERATIVELY. EXPLANTED DEVICE WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834724 ↗
• InjuryNov 20, 2024High impedance; High impedance

  IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR PADDLE LEAD HAD IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR PADDLE LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN DUE TO FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20741081 ↗
• MalfunctionNov 17, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PADDLE LEAD HAD FRACTURED AND CAUSED IMPEDANCES. THE PATIENT UNDERWENT AN SCS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE HOSPITAL KEPT THE EXPLANTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702927 ↗
• InjuryNov 1, 2024Unexpected Therapeutic Results; Device Dislodged or Dislocated; Migration; Unexpected Therapeutic Results; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING. X-RAY SHOWED THAT THE PADDLE LEAD HAD MIGRATED. DURING THE REVISION PROCEDURE, THE PHYSICIAN NOTED THAT ONE OF THE LEAD CONTACTS CAME OFF. THE LEAD WAS REPLACED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: Pain

  MAUDE report 20593753 ↗
• InjuryOct 28, 2024Unexpected Therapeutic Results; Insufficient Device Problem Information; Migration; Unexpected Therapeutic Results; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. MIGRATION WAS THOUGHT TO BE CAUSED BY THE PATIENT EXCESSIVELY ROTATING HER NECK. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WERE NOT RETURNED.

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

  MAUDE report 20549155 ↗
• MalfunctionOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN IMAGING SHOWED THAT THE PATIENT'S DISTAL LEAD CONTACTS WERE DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365901 ↗
• InjuryOct 3, 2024High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT FOLLOWING A NON-DEVICE RELATED PROCEDURE, THE PATIENT EXPERIENCED INADEQUATE STIMULATION. UPON INTERROGATION, IT WAS FOUND THAT PATIENT HAD HIGH IMPEDANCES ON THE PROXIMAL FOUR CONTACTS. THE PATIENT UNDERWENT IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 20360733 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A SUSPECTED LOSS OF MOTOR FUNCTION IN THE LOWER EXTREMITY. THE SUSPECTED OR KNOWN CAUSE OF THE NEUROLOGICAL SYMPTOMS IS UNKNOWN. IT IS UNKNOWN IF THE PHYSICIAN BELIEVES THAT THE EVENT WAS DEVICE RELATED. NOTHING HAPPENED DURING THE SCS IMPLANT PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED.

  Patient problems: Paralysis

  MAUDE report 20208053 ↗
• InjurySep 6, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE DUE TO HIGH IMPEDANCES. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163642 ↗
• MalfunctionJun 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENTS LEAD APPEARED DAMAGE IN THE POCKET DUE TO HEAVY SCAR TISSUE SURROUNDING THE PROXIMAL END OF THE WIRES. THE PHYSICIAN DOES NOT BELIEVE IT IS A DEVICE MALFUNCTION RATHER THAN EXCESSIVE SCAR TISSUE AROUND HER OLD SYSTEM. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN PER HOSPITAL POLICY.

  Patient problems: Scar Tissue

  MAUDE report 19458747 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED NUMBNESS IN BILATERAL LEGS AND DIFFICULTY WITH MOVEMENT OF RIGHT LEG OVERNIGHT AFTER THE SCS IMPLANT PROCEDURE. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED AN EPIDURAL HEMATOMA ABOVE THE LEAD SITE. THE PHYSICIAN ASSESSED THAT A SURGICAL TOOL THAT WAS USED DURING THE IMPLANT PROCEDURE MAY HAVE MADE CONTACT WITH A VEIN CAUSING THE HEMATOMA. THEREFORE, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EVACUATE THE HEMATOMA AND REMOVE THE BLOOD CLOT. NO DEVICES WERE REMOVED AND ALL IMPEDANCES WERE NORMAL. THE PATIENT WAS STABLE POSTOPERATIVELY. THERE WAS NO FURTHER COURSE OF ACTION PLANNED.

  Patient problems: Hematoma; Movement Disorder; Numbness; Thrombosis/Thrombus

  MAUDE report 18992622 ↗
• InjuryFeb 8, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE DUE TO LEAD MIGRATION. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673245 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE CERVICAL REGION DURING THE TRIAL PERIOD. THE PATIENT HAD A FEVER AND ABSCESS WAS NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS DUE TO THE STAGED TRIAL. THE LEAD WAS PULLED A DAY AFTER THE SYMPTOMS WERE OBSERVED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

  Patient problems: Abscess; Bacterial Infection; Fever

  MAUDE report 18511097 ↗

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-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-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-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-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-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-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.