CoverEdge™ X 32 SC-8352-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 08714729832690), received between Dec 7, 2016 and Apr 23, 2026 — classified as 40 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (15 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Unexpected Therapeutic Results; Positioning Problem

  IT WAS REPORTED THAT THE PATIENTS LEAD WAS NOT PROPERLY PLACED BECAUSE THE PHYSICIAN HAD DIFFICULTY WITH THE PLACEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED TO CAPTURE PATIENTS PAIN AREAS. DURING THE REVISION, THE PHYSICIAN WAS NOT CAREFUL WHEN MOVING THE LEAD AND CONTACTS FELL OFF THE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Pain

  MAUDE report 24967577 ↗
• InjuryOct 22, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THEIR SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENTS' PROGRAMS WERE OPTIMIZED HOWEVER THE ISSUE PERSISTED. IMAGING WAS PERFORMED WHICH REVEALED THE PADDLE LEAD MIGRATED OUT OF THE EPIDURAL SPACE AND FOLDED BACK ON ITSELF. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PADDLE LEAD WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT IS DOING WELL POSTOPERATIVELY AND REPORTED GOOD PAIN COVERAGE.

  Patient problems: Pain

  MAUDE report 23357598 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689820 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED INCREASING STENOSIS FROM THE SIZE OF THE PADDLE LEAD. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE, AND THE PHYSICIAN OPTED TO USE A SMALLER FOOTPRINT PADDLE LEAD AND PLACED IT AT A NON-STENOSIS AREA. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICE WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Discomfort

  MAUDE report 20377267 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PUS, REDNESS, AND SWELLING AT THE LEAD INSERTION SITE. THE PATIENTS WIFE HAD BEEN TREATING THIS ON HER OWN WITH PEROXIDE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS BY THEIR GENERAL PRACTITIONER, AND LATER ADMINISTERED A DIFFERENT TYPE OF ANTIBIOTICS FROM THEIR SPINAL CORD STIMULATION PHYSICIAN. THE PHYSICIAN ASSESSED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND PROCEDURE ARE CONTRIBUTING FACTORS TO THE INFECTION, ALONG WITH THE FACT THAT THE PATIENT REFUSED TO REPORT FOR FOLLOW-UP VISITS AS INSTRUCTED BY THE IMPLANT TEAM. A CULTURE WAS TAKEN WHICH CONFIRMED STAPHYLOCOCCUS INFECTION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE MEDICAL FACILITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection; Erythema; Purulent Discharge; Swelling/ Edema

  MAUDE report 19076788 ↗
• InjuryNov 20, 2023High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON THE LEAD FOLLOWING A REVISION PROCEDURE REPORTED IN 3006630150-2023-05955. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18172873 ↗
• InjuryOct 30, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD SOME DISCOMFORT AT THE IPG SITE DUE TO THE LEADS HAD WORKED THEIR WAY IN FRONT OF THE GENERATOR AND HAD AN UNCOMFORTABLE RUBBING SENSATION. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE AND DOING WELL POST OPERATIVELY. NOTHING WAS EXPLANTED.

  Patient problems: Pain

  MAUDE report 18034392 ↗
• InjurySep 6, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH AN X RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD AND IPG WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688004 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW HOURS AFTER THE SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INCREASED BLOOD LOSS AND PARALYSIS IN THE LEGS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE PADDLE LEAD AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER POSTOPERATIVELY. THE LOCATION OF THE LEAD AND AREA OF BLOOD LOSS WAS UNABLE TO BE OBTAINED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Paralysis

  MAUDE report 17637434 ↗
• InjuryAug 5, 2022Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15180265 ↗
• InjuryJun 15, 2022Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND THE PHYSICIAN BELIEVED THAT IT WAS MOST LIKELY DUE TO LEAD MIGRATION. MULTIPLE REPROGRAMMING WAS DONE BUT WAS UNSUCCESSFUL IN GETTING COVERAGE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14700270 ↗
• InjuryMay 21, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT LEAD WAS PLACED LATERALLY AND NEEDED TO BE IMPLANTED MIDLINE FOR BILATERAL COVERAGE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN PER HOSPITAL POLICY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14466463 ↗
• InjuryMay 18, 2022Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION OF THE TARGETED PAIN AREA; BILATERAL BACK AND LEGS. MULTIPLE REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, ONLY THE LEFT INNER THIGH WAS ABLE TO OBTAIN COVERAGE. AN X-RAY WAS PERFORMED WHICH CONFIRMED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14432186 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MORNING FOLLOWING A SPINAL CORD STIMULATOR PADDLE LEAD IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BILATERAL LOWER EXTREMITY PARALYSIS YET HAD SOME FEELING IN THE LEGS. A MAGNETIC RESONANCE IMAGE MRI WAS NEEDED, HOWEVER, THE DEVICE NEEDED TO BE EXPLANTED PRIOR TO IMAGING PER THE INSTRUCTIONS FOR USE, IFU. THE PHYSICIAN ASSESSED IT WOULD BE SAFEST TO REMOVE THE PADDLE LEAD IN CASE THERE WAS SWELLING OR FLUID ACCUMULATION IN THE EPIDURAL SPACE CAUSING COMPRESSION OF THE SPINAL CORD. THEREFORE, THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND OBTAINED THE MRI. THE POST-EXPLANT MRI DISPLAYED AN EPIDURAL HEMATOMA FROM THE T6 TO THE T11 VERTEBRAE. THE PATIENT WAS INTUBATED AND ON A VENTILATOR. THERE WERE PLANS TO EXTUBATE THE PATIENT AND PLACE ON PALLIATIVE CARE, HOWEVER, NO FURTHER INFORMATION HAS BEEN OBTAINED REGARDING THE PATIENT STATUS DESPITE THREE GOOD FAITH EFFORT ATTEMPTS. THE LEAD WAS EASILY INSERTED DURING THE IMPLANT PROCEDURE AND THERE WERE NO PROCEDURAL COMPLICATIONS NOTED AT TIME OF IMPLANT NOR EXPLANT. THE PADDLE LEAD WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: Hematoma; Paralysis

  MAUDE report 14247353 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW HOURS FOLLOWING A SPINAL CORD STIMULATION PADDLE LEAD IMPLANT PROCEDURE THE PATIENT EXPERIENCED A FEELING OF VIBRATION IN THEIR LEGS, FOLLOWED BY DIFFICULTY MOVING, AND LATER PARTIAL PARALYSIS. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE DEVICE WAS REPLACED AND THE SYMPTOMS DISAPPEARED. THE PATIENT IS DOING WELL POST-OPERATIVELY.

  Patient problems: Paralysis; Undesired Nerve Stimulation

  MAUDE report 14062872 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW HOURS FOLLOWING A SPINAL CORD STIMULATION PADDLE LEAD IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A FEELING OF VIBRATION IN THEIR LEGS AND LATER PARTIAL PARALYSIS. THE PADDLE LEAD WAS EXPLANTED AND THEN THE PATIENTS SYMPTOMS DISAPPEARED. THE PATIENT THEN HAD TWO INFINION LEADS PLACED AND WAS DOING WELL POST-OPERATIVELY.

  Patient problems: Paralysis; Undesired Nerve Stimulation

  MAUDE report 14054372 ↗
• InjuryFeb 11, 2022Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. X-RAY IMAGES SHOWED THE LEAD HAD MIGRATED LATERALLY. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE LEAD. THE PATIENT WAS NOTED TO HAVE FULLY RECOVERED POST-OPERATIVELY. THE EXPLANTED LEAD WAS DISPOSED AND WAS NOT RETURNED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13516273 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834530 ↗
• MalfunctionJun 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A BOTTOM ROW OF CONTACTS WERE DETACHED WHICH WAS CONFIRMED VIA X-RAY. THE PHYSICIAN OPTED TO REPLACE THE LEAD AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12068458 ↗
• InjuryMay 18, 2021Difficult to Remove; Unexpected Therapeutic Results; Difficult to Remove; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENTS OLD PADDLE WAS UP TOO HIGH FROM WHERE THE TRIAL WAS YEARS AGO AND WAS ALSO NOT GETTING ADEQUATE PAIN RELIEF. THE PHYSICIAN INITIALLY PLANNED TO REPLACE THE WHOLE SYSTEM BUT WAS UNABLE TO GET THE OLD PADDLE OUT, AND THEREFORE LEFT THE PADLDLE LEAD AND CUT THE TAILS OFF. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS EXPLANTED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840071 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD SITE. IT WAS NOTED THAT THE PATIENT HAD SWELLING AND PUSS AT THE LEAD SITE. IT WAS UNKNOWN AS TO WHAT CAUSED THE INFECTION. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE. THE PATIENT WAS GIVEN ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED SINCE IT WAS NOT RELEASED BY THE MEDICAL FACILITY.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11664712 ↗
• InjuryFeb 11, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS ADJUSTED. THE PATIENT WAS REPROGRAMMED POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314550 ↗
• InjuryJun 26, 2020Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO THE LEAD THAT HAD MIGRATED TWO LEVELS DOWN FROM ORIGINAL PLACEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED IN THE PATIENTS BODY.

  Patient problems: No Code Available

  MAUDE report 10200643 ↗
• InjuryMar 20, 2020Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION AND WAS IN A LOT OF PAIN IN THE STOMACH. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

  Patient problems: Abdominal Pain; No Code Available

  MAUDE report 9863235 ↗
• InjuryJul 18, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS REPORTEDLY DOING WELL POST OPERATIVELY.

  Patient problems: No Code Available

  MAUDE report 8805740 ↗

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-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-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-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-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.