CoverEdge™ MRI SC-8436-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729995821), received between Aug 3, 2022 and Jun 23, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589184 ↗
• InjuryMar 31, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENTS PADDLE SPINAL CORD STIMULATOR (SCS) LEAD HAD MIGRATED. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF AND WAS GETTING STIMULATION IN NON-TARGET AREAS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24747665 ↗
• InjuryAug 14, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT COULD NO LONGER FEEL THE STIMULATION AFTER GOING FROM A STANDING TO SITTING POSITION. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS NOT SUCCESSFUL. IMAGING WAS TAKEN WHICH CONFIRMED THAT THE PADDLE LEAD MIGRATED OUT OF THE EPIDURAL SPACE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Pain

  MAUDE report 22812676 ↗
• InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THORACIC PAIN AT THE PADDLE LEAD SITE SINCE THE INITIAL IMPLANT PROCEDURE. THE PHYSICIAN ASSESSED THAT THE PAIN MAY BE DUE TO THE LAMINECTOMY PERFORMED TO PLACE THE PADDLE LEAD. ADDITIONALLY, THE STIMULATION THERAPY INITIALLY WORKED WELL IN THE FIRST FIVE MONTHS, HOWEVER, IT HAS SINCE DECREASED. REPROGRAMMING WAS ATTEMPTED HOWEVER, THE EVENT PERSISTS, THE PATIENT UNDERWENT A THORACIC RADIO FREQUENCY (RF) PROCEDURE AND IS CONTENT WITH THE CURRENT SITUATION.

  Patient problems: Pain

  MAUDE report 20892764 ↗
• InjuryJun 23, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE TO PUT THE PADDLE BACK IN PLACE HOWEVER AFTER THE PHYSICIANS NUMEROUS ATTEMPTS IT WAS NOT SUCCESSFUL. THE PROCEDURE HAS BEEN ABORTED.

  Patient problems: Pain

  MAUDE report 19591659 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION PADDLE LEAD BEGAN TO ERUPT ON THE PATIENTS SKIN MAKING HER FEEL VERY UNCOMFORTABLE. IT IS NOT KNOWN IF THE LEAD BROKE THROUGH THE SKIN. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PADDLE LEAD WAS EXPLANTED. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED AT THE FACILITY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Erosion; Vomiting

  MAUDE report 19472874 ↗
• InjuryMay 24, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT DURING THE INITIAL POST OPERATIVE PROGRAMMING SESSION THE PATIENT DID NOT RECEIVE ADEQUATE STIMULATION IN THE LEFT ARM FROM THE PADDLE LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. IT WAS THEN STATED THAT THE PATIENT WAS FEELING STIMULATION IN THEIR FACE. A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED AND CONFIRMED THAT THE BOTTOM OF THE PADDLE LEAD WAS LEFT SIDED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PADDLE LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) WERE REPLACED. THE PATIENT IS DOING WELL POST OPERATIVELY. NO DEVICES WILL BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY PER PROTOCOL.

  Patient problems: Movement Disorder; Pain

  MAUDE report 19397923 ↗
• InjuryApr 9, 2024Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT PATIENTS LEADS HAD MIGRATED AND WAS NOTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF, THE PATIENT UNDERWENT A LEAD REPOSITIONING PROCEDURE AND WAS DOING WELL POST OPERATIVELY.

  Patient problems: Pain

  MAUDE report 19075728 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION AT THE UPPER LEAD INCISION SITE. SYMPTOMS OF PAIN, DISCHARGE AND IMPAIRED WOUND HEALING WERE NOTED. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF INFECTION AND OPTED TO CLEAN OUT THE INFECTED SITE. THE PATIENT WAS THEN REFERRED TO AN INFECTIOUS DISEASE DOCTOR, WAS PUT ON ANTIBIOTICS AND HAD A HOME NURSE CHANGE THE BANDAGE WEEKLY. THE PATIENT IS REPORTEDLY DOING WELL AND THE INFECTION AT THE INCISION SITE HAS CLEARED UP.

  Patient problems: Bacterial Infection; Discomfort; Fluid Discharge; Impaired Healing; Pain

  MAUDE report 18335884 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT WOKE WITH NUMBNESS AND LOSS OF SENSATION IN LEGS. THE TIME BETWEEN THE PADDLE LEAD IMPLANT AND THE ONSET OF SYMPTOMS WAS 30 MINUTES. THE PHYSICIAN ASSESSED THAT THERE WAS A BUILD-UP OF BLOOD, CAUSING PRESSURE. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE SCS PADDLE LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED. THE PHYSICIAN DOES NOT FEEL THE EVENT WAS DEVICE RELATED BUT WANTED TO RULE OUT ANY POSSIBLE INVOLVEMENT. THE PATIENT HAS RECOVERED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY.

  Patient problems: Hematoma; Numbness; Paralysis

  MAUDE report 17239898 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL OR MOVE HIS LEGS AFTER BEING IMPLANTED WITH THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PHYSICIAN ASSESSED THE PATIENT HAD DEVELOPED A HEMATOMA IN THE SPINAL COLUMN DUE TO AN EPIDURAL TEAR THAT WAS RELATED TO THE PROCEDURE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE ENTIRE SCS SYSTEM WAS REMOVED. THE PATIENT DID WELL POST-OPERATIVELY AND WAS ADMITTED TO A REHABILITATION FACILITY WHERE HE REGAINED MOBILITY. THE EXPLANTED DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Hematoma; Laceration(s); Numbness; Paralysis

  MAUDE report 15161370 ↗

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-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-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-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-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.