CoverEdge™ X 32 SC-8352-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 08714729832683), received between Dec 5, 2016 and Sep 30, 2026 — classified as 68 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (18 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 74 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954928 ↗
• MalfunctionDec 30, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD WAS SUSPECTED TO BE FRACTURED. IT WAS NOTED THAT THE PATIENT FELL DIRECTLY ONTO THEIR BACK AND WOULD LIKE THE LEAD EXAMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930714 ↗
• MalfunctionDec 8, 2025Fracture; High impedance; Adverse Event Without Identified Device or Use Problem; Fracture; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD HAD HIGH IMPEDANCES, FOUND DURING DEVICE OPTIMIZATION. POSSIBLE FRACTURE LEAD WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750747 ↗
• InjuryJun 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350780 ↗
• InjuryApr 29, 2025Migration; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR PADDLE LEAD MIGRATED. 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 21924053 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858214 ↗
• InjuryNov 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692095 ↗
• InjuryOct 15, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THE LEAD OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. REPROGRAMMING WAS PERFORMED BUT DID NOT PROVIDE PAIN RELIEF. IMAGING WAS PERFORMED AND CONFIRMED THE PLACEMENT OF THE LEAD AT THE T5, PER PHYSICIAN REVIEW HE STATED THAT THE LEAD WAS PLACED TOO HIGH. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD WAS REPOSITIONED TO T9-T11. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPOSITIONED IN THE POCKET AND RE-ANCHORED TO A BETTER POSITION FOR PATIENT COMFORT AND CHARGING CAPABILITIES. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY ALL REMAIN IMPLANTED.

  Patient problems: Pain

  MAUDE report 20453947 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO THE PATIENT REPORTED PAIN LOCATED AT HER BACK. NEUROSURGEON STATED THAT THE PAIN AND THE PADDLE WERE NOT CORRELATED. THE SURGEON AGREED TO THE PATIENT'S REQUEST TO REMOVE THE SURGICAL PADDLE AND IMPLANT PERCUTANEOUS LEADS INSTEAD. THE PATIENT IS DOING WELL POST OPERATIVELY. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS NOT USED.

  Patient problems: Pain

  MAUDE report 20407845 ↗
• InjuryMar 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAN FEEL THE LEADS THROUGH THE SKIN THAT WAS CAUSING DISCOMFORT.

  Patient problems: Discomfort; Erosion

  MAUDE report 18919077 ↗
• InjuryJun 16, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS CONFIRMED THROUGH IMAGING AND TESTING THAT THE PADDLE LEAD WAS IMPLANTED UPSIDE DOWN. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 17141862 ↗
• MalfunctionApr 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A TWO MISSING CONTACTS ON THE PADDLE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787156 ↗
• InjuryApr 21, 2023Unexpected Therapeutic Results; Device Dislodged or Dislocated; Migration; Unexpected Therapeutic Results; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DESPITE REPROGRAMMING DONE DUE TO LEAD MIGRATION. IT WAS ALSO NOTED THAT THERE WERE MISSING CONTACTS ON THE PADDLE LEAD. THE PATIENT UNDERWENT A PADDLE LEAD REPOSITIONING PROCEDURE.

  Patient problems: Pain

  MAUDE report 16785174 ↗
• InjuryMar 20, 2023Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION. IT WAS STATED THAT THE PATIENTS PADDLE LEAD HAD MOVED AND WAS CONFIRM THROUGH IMAGING. THE PHYSICIAN BELIEVED THAT IT WAS DUE TO A SNEEZING FIT. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574121 ↗
• InjuryMar 17, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565185 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT THAT WAS IN THE MIDST OF A 2-STAGE SCS TRIAL, ARRIVED AT THE HOSPITAL FOR THE SECOND STAGE OF THE PROCEDURE. DURING PRE-OPERATIVE TESTING, THE PATIENT WAS FOUND TO HAVE AN INCREASED TEMPERATURE, DECREASED BLOOD PRESSURE, AND EXPERIENCED CONFUSION. THE PATIENT WAS ADMITTED TO THE ER AND THE PROCEDURE WAS PUT ON HOLD. THE PATIENT WAS DIAGNOSED WITH SEPSIS AND ADMITTED TO THE ICU. THE PATIENT REMAINED IN THE ICU AND WAS BEING INVESTIGATED FOR MENINGITIS. THE PATIENT WAS THEN TRANSFERRED OUT OF THE ICU AND THE IMPLANT PROCEDURE WAS COMPLETED. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. IT IS NOT KNOWN IF THE DEVICE OR PROCEDURE CONTRIBUTED TO THIS EVENT.

  Patient problems: Confusion/ Disorientation; Fever; Low Blood Pressure/ Hypotension; Sepsis; Unspecified Infection

  MAUDE report 15921037 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTENSE MUSCLE SPASMS FREQUENCY AND WEAKNESS ON THE LEGS, FOOT AND HIPS. THE PATIENT UNDERWENT A PROCEDURE WHEREIN SPINAL CORD STIMULATOR WAS REMOVED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Muscle Weakness/Atrophy; Numbness

  MAUDE report 14875650 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE SPINAL CORD STIMULATION LEAD IT WAS NOTED THAT SPINAL ACCESS WAS MORE CHALLENGING DUE TO A PREVIOUS FUSION BUT FOLLOWING THAT, THE LEAD PLACEMENT WAS STRAIGHT FORWARD. THE PHYSICIAN NOTICED A SMALL AMOUNT OF CLEAR FLUID IN THE WOUND DURING CLOSURE SO HE USED A SEALANT IN THE EVENT THAT THE FLUID WAS CEREBROSPINAL FLUID (CSF) LEAKAGE. OVER THE NEXT FEW DAYS, THE PATIENT DEVELOPED A SEVERE HEADACHE WHICH WAS CONSISTENT WITH A CSF LEAK WHICH ALSO CONTRIBUTED TO A LACK OF MOBILITY. AS THIS SYMPTOM PERSISTED, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE LEAD. THE PATIENT HAD SOME POST OPERATIVE PAIN BUT IS EXPECTED TO FULLY RECOVER. THE LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 14215220 ↗
• InjuryApr 20, 2022High impedance; Unexpected Therapeutic Results; High impedance; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE EXPLANTED LEAD WAS NOT RETURNED AS THERE WAS NO DEVICE MALFUNCTION SUSPECTED AND WAS KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14164206 ↗
• InjuryApr 8, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A PADDLE LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED PADDLE LEAD WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14053449 ↗
• InjuryFeb 25, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596747 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANT CASE THAT WAS ABORTED DUE TO AN UNKNOWN REASON WHICH WAS EITHER DEVICE OR PROCEDURE RELATED.

  Patient problems: Insufficient Information

  MAUDE report 13289136 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATOR LEAD TRIAL, THE PATIENT STATED HE FELT LEG WEAKNESS THROUGHOUT THE FIVE DAYS OF THE TRIAL, HOWEVER, THE TRIAL WAS SUCCESSFUL. THEREFORE, THE PATIENT UNDERWENT A PERMANENT PADDLE LEAD IMPLANT PROCEDURE. WHILE THE PATIENT WAS IN PRE-OP FOR THIS IMPLANT PROCEDURE, AND THE FOLLOWING DAY, THE PATIENT STATED HE WAS UNABLE TO MOVE HIS LEGS. A MAGNETIC RESONANCE IMAGING MRI SCAN WAS TAKEN AND DISPLAYED THECAL SAC COMPRESSION AND AN EPIDURAL HEMATOMA AT THE THORACIC VERTEBRAE T12 THROUGH T9. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE THE DAY AFTER THE IMPLANT PROCEDURE WHEREIN THE HEMATOMA WAS REMOVED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. POST-OPERATIVELY, THE PATIENT IS RECOVERING AND HAS NOT YET GAINED BACK MOVEMENT BUT HAS SOME RETURNING SENSATION. THE PHYSICIAN NOTED THAT RECOVERY COULD TAKE THREE TO FOUR WEEKS. THE PHYSICIAN ASSESSED THE DEVICE IN COMBINATION WITH THE HEMATOMA AND SOME EPIDURAL NARROWING CONTRIBUTED TO THE EVENT. THE PATIENTS SYMPTOMS WERE CAUSED BY THE COMPRESSION OF THE THECAL SAC DUE TO THE COMBINATION OF THE LEAD AND THE HEMATOMA.

  Patient problems: Hematoma; Muscle Weakness/Atrophy; Paralysis

  MAUDE report 13006780 ↗
• InjuryNov 15, 2021Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS GETTING INADEQUATE PAIN RELIEF. X-RAY SHOWED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS KEPT BY MEDICAL FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12813735 ↗
• InjuryOct 22, 2021Fracture; Unexpected Therapeutic Results; Migration; Fracture; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO THE LEAD FALLING OUT OF THE EPIDURAL SPACE AS CONFIRMED THROUGH X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS SUPPOSED TO BE MOVED BACK IN ITS PLACE HOWEVER THERE WERE TEARS IN THE BASE OF THE PADDLE LEAD THAT THE PHYSICIAN OPTED FOR A LEAD REPLACEMENT INSTEAD. THE EXPLANTED LEAD WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12680457 ↗

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-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-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-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-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.