CoverEdge™ MRI SC-8436-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729995814), received between Jun 7, 2021 and Jul 21, 2026 — classified as 47 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (22 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 49 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD WAS TORN OFF IN A VIOLENT CAR CRASH. IT WAS UNKNOWN IF CAR ACCIDENT WAS DEVICE RELATED. AS A RESULT, THE STIMULATION SETTING HAD TO BE INCREASED TO 100 TO ACHIEVE STIMULATION, WHICH CAUSED PAIN. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 25892716 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INCISION SITE THAT WRAPPED AROUND THE STOMACH FOLLOWING THE IMPLANT PROCEDURE. THE PHYSICIAN SUSPECTED EPIDURAL HEMATOMA, WHICH WAS BELIEVED TO BE NOT DIRECTLY RELATED TO THE DEVICE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

  Patient problems: Hematoma; Implant Pain

  MAUDE report 25786564 ↗
• InjuryMay 1, 2026Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 25057719 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS DUE TO THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WAS COMPRESSING ON THE SPINAL CORD. THE PATIENT UNDERWENT A SCS PADDLE LEAD REPLACEMENT, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 24571125 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A NEW EXCRUCIATING PAIN AT THE PADDLE LEAD INCISION SITE ALONG THE RIGHT SIDE OF THE BACK. IT WAS NOTED THAT THE PAIN WAS NOT DEVICE OR PROCEDURE RELATED AND THE ISSUE HAS BEEN RESOLVED. THE PATIENT WAS DOING WELL UPON FOLLOW-UP.

  Patient problems: Implant Pain

  MAUDE report 24339755 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073121 ↗
• InjurySep 18, 2025Migration; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) HAD SPUN IN THE POCKET CAUSING THE PATIENT TO EXPERIENCE PAIN. IT WAS NOTED THAT THE DEVICE MIGRATION WAS CONFIRMED THRU X-RAY IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT AND IPG REPOSITIONING PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.

  Patient problems: Pain

  MAUDE report 23089934 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS AT THE BOTTOM OF THE FEET. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) PADDLE LEAD EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Numbness

  MAUDE report 22879840 ↗
• InjuryAug 15, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE COVERAGE DUE TO 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 22820101 ↗
• InjuryJun 19, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT HAS NEVER RECEIVED ADEQUATE PAIN RELIEF FROM HIS SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENTS SYSTEM WAS REPROGRAMMED MULTIPLE TIMES HOWEVER THE ISSUE PERSISTED. IMAGING WAS PERFORMED WHICH REVEALED SLIGHT MIGRATION OF THE SCS PADDLE LEAD. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 22292333 ↗
• InjuryMay 26, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED WITH MEDICATION DUE TO AN INFECTION AT THE LEAD SITE. PATIENT HAD A LOT OF DRAINAGE, AND HER MIDLINE INCISION WAS SLIGHTLY OPEN. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED, AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION DUE TO A LEAD MIGRATION.

  Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence

  MAUDE report 22084996 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Unspecified Infection

  MAUDE report 22044807 ↗
• InjuryMay 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN LOWER EXTREMITY WEAKNESS. HIGH IMPEDANCES WERE NOTED ON THE PADDLE LEAD. X-RAY WAS TAKEN AND SHOWED STABLE PADDLE LEAD PLACEMENT. THE PATIENT UNDERWENT A PADDLE LEAD EXPLANT PROCEDURE. THE EXPLANTED DEVICE WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22026030 ↗
• MalfunctionMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PLACEMENT OF SPINAL CORD STIMULATOR TRIAL PADDLE LEADS, NEUROMONITORING WAS LOST ON THE RIGHT SIDE. CONSEQUENTLY, THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND REMOVE THE PADDLE LEAD. POST-OPERATIVELY, THE PATIENT IS REPORTED TO BE DOING WELL. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS DISPOSED AT THE FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 22015939 ↗
• MalfunctionApr 9, 2025Fracture; Unexpected Therapeutic Results; Fracture; Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD BROKEN OFF FROM THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENTS SPINAL CORD STIMULATOR LEAD WAS EXPLANTED.

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

  MAUDE report 21810643 ↗
• InjuryFeb 18, 2025High impedance; High impedance

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING BACK PAIN SLIGHTLY LESS, BUT THEN RIGHT LEG/GROIN GOES NUMB. IT WAS ALSO NOTED THAT SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT PADDLE REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED PER FACILITY POLICY.

  Patient problems: Numbness; Undesired Nerve Stimulation

  MAUDE report 21405926 ↗
• InjuryJan 28, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND IT WAS DISCOVERED THAT THE IMPLANTED PADDLE LEAD HAD MIGRATED THREE VERTEBRAL BODIES UP. THEREFORE, THE PATIENT UNDERWENT A PROCEDURE DURING WHICH TWO NEW LEADS WERE IMPLANTED. THE TAILS OF THE EXISTING PADDLE LEAD WERE DISCONNECTED FROM THE IMPLANTABLE PULSE GENERATOR (IPG) IN ORDER TO MAKE ROOM FOR THE NEW LEAD ADDITIONS HOWEVER, IT REMAINED IMPLANTED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT WAS EXPECTED TO FULLY RECOVER POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 21261134 ↗
• InjuryNov 26, 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 UNDERWENT A PERMANENT IMPLANT PROCEDURE OF THE SCS SYSTEM AND IT WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS INTRAOPERATIVELY. THE PADDLE LEAD WAS PLACED AT THE TOP OF THE NINTH THORACIC VERTEBRAL LEVEL. HOWEVER, A FEW MINUTES AFTER THE PROCEDURE, THE PATIENT EXPERIENCED PARALYSIS OF HER LEGS AND FEET. MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED HOWEVER THE RESULTS WERE NOT MADE AVAILABLE. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE SCS SYSTEM. THE PATIENT REGAINED MOVEMENT OF HER LEGS AND FEET POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THE MEDICAL FACILITY DID NOT RELEASE THEM.

  Patient problems: Paralysis

  MAUDE report 20780701 ↗
• InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PADDLE SPINAL CORD STIMULATION (SCS) LEAD WAS REPOSITIONED DUE TO HAVING INTERCOSTAL PAIN FROM A PADDLE LEAD BEING TOO LATERAL. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 20647647 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANT PROCEDURE, THE PATIENTS LEFT LEG DOWN TO THE KNEE WAS NUMB AND WEAK, AND THE PATIENT WAS UNABLE TO URINATE. IT WAS NOTED THAT A HEMATOMA DEVELOPED IN THE PATIENTS ARM. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED AND RETAINED BY THE MEDICAL FACILITY. THE HEMATOMA HAD BEEN REMOVED AND THE PATIENT WAS PUT IN THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN CONFIRMED THAT THE HEMATOMA WAS NOT DEVICE RELATED AND THAT IT WAS DUE TO PATIENTS BLOOD DISORDER THAT MAKE PLATELETS SLOW TO CLOT. UPON FOLLOW-UP, THE PATIENTS LEFT LEG NUMBNESS AND WEAKNESS WAS IMPROVING.

  Patient problems: Hematoma; Muscle Weakness/Atrophy; Numbness; Urinary Retention

  MAUDE report 20591554 ↗
• InjuryOct 17, 2024Migration; Migration

  IT WAS REPORTED THAT THE LEAD WAS POKING THROUGH THE SPINE AREA AND UNDER THE PATIENTS SKIN. THE PATIENT ALSO NOTED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. IMAGING WAS TAKEN WHICH SHOWED THAT THE LEAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED, THE IPG WAS REPLACED AND THE POCKET SITE WAS RELOCATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Discomfort; Erosion

  MAUDE report 20471467 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RECENTLY IMPLANTED PATIENT EXPERIENCED LOSS OF FUNCTION IN THEIR LEGS AND EXPERIENCED SEVERE PAIN. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED TWO HEMATOMAS. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM. THE PATIENT HAS REGAINED FUNCTION IN THEIR LEGS AND THE PAIN HAS IMPROVED.

  Patient problems: Hematoma; Pain; Paralysis

  MAUDE report 20048991 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A STAPH INFECTION IN THE UPPER INCISION WHERE THE PADDLE WAS PLACED. SYMPTOMS OF SORENESS, REDNESS, PUFFINESS, AND SOME YELLOW AND WHITE DISCHARGE WERE NOTED. THE PATIENT UNDERWENT A FULL SYSTEM EXPLANT AND WAS PRESCRIBED ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

  Patient problems: Bacterial Infection; Erythema; Fluid Discharge; Pain

  MAUDE report 19652344 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED BLEEDING FROM THE SPINAL CORD STIMULATION (SCS) PADDLE LEAD INCISION SITE. THE PATIENTS GENERAL PRACTIONER (GP) EVALUATED THE PATIENT AND NOTED THAT THE SITE HAD SLIGHTLY OPENED UP AND WAS OOZING. A CULTURE WAS TAKEN WHICH CONFIRMED INFECTION. THE PATIENT WAS TREATED WITH TEN-DAY COURSE OF FLUCOXACILLIN ANTIBIOTICS. THE PATIENT WAS LATER RE-EVALUATED AND IS HEALING NICELY AS THE INFECTION APPEARS TO HAVE RESOLVED.

  Patient problems: Abscess; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 19496654 ↗
• InjuryApr 3, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. IMAGING TAKEN SHOWED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037686 ↗

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-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-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-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-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-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.