Artisan™ MRI SC-8416-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 08714729951124), received between Sep 8, 2017 and Jul 7, 2026 — classified as 104 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (39 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 108 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION FOLLOWING A FALL, WHICH WAS CONFIRMED THROUGH IMAGING STUDIES. UPON EVALUATION, THE PHYSICIAN OBSERVED THAT THE MIDLINE SPINAL INCISION APPEARED SUSPICIOUS, THOUGH NO EXTERNAL DRAINAGE WAS PRESENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FURTHER ASSESSMENT. DURING SURGICAL EXPLORATION OF THE SPINAL INCISION, SUSPICIOUS FLUID WAS ENCOUNTERED WITHIN THE MIDLINE INCISION CAVITY. BOTH SUPERFICIAL AND DEEP CULTURES WERE OBTAINED FOR ANALYSIS. SUBSEQUENTLY, THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. POSTOPERATIVELY, THE PATIENT WAS ADMITTED FOR INPATIENT CARE AND WILL BE INITIATED ON ANTIBIOTIC THERAPY. EXPLANTS DISCARDED PER FACILITY BIOHAZARD PROTOCOL.

  Patient problems: Bacterial Infection; Fluid Discharge; Pain; Wound Dehiscence

  MAUDE report 25740370 ↗
• InjuryMar 30, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION DUE TO LEAD MIGRATION THAT WAS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24714016 ↗
• InjuryNov 27, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND FEELING STRONG UNWANTED STIMULATION. THE SPINAL CORD STIMULATION (SCS) PADDLE MIGRATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 23665497 ↗
• 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 PAIN AT THE LEAD INCISION SITE AND WENT THE EMERGENCY ROOM. THE PATIENTS PAIN WAS DEEMED TO BE POSTOPERATIVE PAIN. THE PATIENT WAS PRESCRIBED WITH PAIN MEDICATIONS AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS DOING WELL.

  Patient problems: Implant Pain

  MAUDE report 23638234 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A PADDLE LEAD IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING LOWER EXTREMITY WEAKNESS AND WAS UNABLE TO MOVE THE LOWER EXTREMITIES. THE PHYSICIAN INSTRUCTED THE PATIENT TO BE TAKEN TO THE HOSPITAL.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22305262 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEAD WAS BROKEN IN HALF WHICH WAS CONFIRMED THROUGH X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088036 ↗
• InjuryMar 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT NEEDED AN MRI; THEREFORE, THE SPINAL CORD STIMULATOR SYSTEM WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704047 ↗
• InjuryFeb 20, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) LEAD REPLACEMENT PROCEDURE DUE TO MIGRATION AS CONFIRMED VIA X-RAY. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPLACED DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21427676 ↗
• InjuryNov 26, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD MIGRATED AND WAS NOTED THAT PATIENT HAD LOSS ITS COVERAGE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785074 ↗
• InjuryNov 1, 2024High impedance; Failure to Disconnect; High impedance; Failure to Disconnect

  IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCES. DURING THE PROCEDURE TO REPLACE THE LEAD, THE LEAD WOULD NOT DISCONNECT FROM THE IMPLANTABLE PULSE GENERATOR (IPG) AS THE PORT SCREWS WOULD NOT DISENGAGE. THE PHYSICIAN OPTED TO REPLACE BOTH LEAD AND IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588499 ↗
• InjuryOct 18, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479328 ↗
• InjurySep 20, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH AN X-RAY. THE PHYSICIAN WAS UNSUCCESSFUL IN REPOSITIONING THE LEAD AND DECIDED TO REMOVE THE PADDLE LEAD. 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 20274265 ↗
• InjuryAug 20, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PADDLE LEAD HAD BACKED OUT OF PLACE AND PATIENTS THERAPY WAS LOST. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001351 ↗
• MalfunctionAug 3, 2024Fracture; Unexpected Therapeutic Results; Fracture; Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENT HAD STOPPED CHARGING AS STIMULATION WAS NOT PROVIDING ADEQUATE RELIEF. IT WAS FOUND DURING X-RAY THAT PATIENT HAD A SPINAL CORD STIMULATION (SCS) LEAD FRACTURED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 19902342 ↗
• InjuryJul 12, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED AS REVEALED FROM XRAY. THE PATIENT UNDERWENT A LEAD REPOSITIONED PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NOTHING WAS EXPLANTED OR ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733575 ↗
• MalfunctionJul 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD CONTACTS CAME OFF AND THIS WAS CONFIRMED THROUGH IMAGING. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684824 ↗
• InjuryJun 18, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND RIB STIMULATION FOLLOWING AN UPGRADE PROCEDURE. REPROGRAMMING WAS ATTEMPTED, HOWEVER, UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE PADDLE LEAD WAS REPLACED AND RELOCATED TO ACHIEVE BETTER COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 19562795 ↗
• InjuryMay 16, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO PADDLE LEAD POSITIONED TOO LATERAL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) REPLACEMENT AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 19336694 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMAGING DONE WHICH CONFIRMED A POOR LEAD PLACEMENT. THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244446 ↗
• InjuryMar 25, 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 NOT RELEASED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970671 ↗
• InjuryJan 27, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE LEAD MIGRATED IN THE SPINE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND NO DEVICE WILL BE RETURN AS THE PRODUCT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592791 ↗
• InjuryJan 5, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DESPITE REPROGRAMMING. X-RAY CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: Pain

  MAUDE report 18451300 ↗
• InjuryJan 4, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE MIDLINE INCISION SITE WHEN PATIENT LEANS ON IT. X-RAY SHOWED THAT THE PADDLE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE, WHEREIN THE PHYSICIAN FIXED THE LEAD TAIL WHICH HERNIATED THROUGH THE PATIENTS FASCIA. NO PRODUCT WAS ADDED OR REMOVED. THE PATENT WAS DOING WELL POST-OPERATIVELY.

  Patient problems: Implant Pain

  MAUDE report 18443808 ↗
• InjuryDec 6, 2023High impedance; High impedance

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING SHARP PAIN. HIGH IMPEDANCES WERE ALSO NOTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 18274786 ↗
• InjuryDec 2, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A PADDLE REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED PRODUCT WILL NOT BE RETURNED BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 18253381 ↗

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-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-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-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.