CoverEdge™ 32 SC-8336-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 802 adverse event reports that list this exact device (DI 08714729832669), received between Dec 6, 2016 and Sep 29, 2026 — classified as 751 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Migration” (309 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 802 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Nonstandard Device; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Migration

  Patient problems: Inappropriate Device Stimulation of Tissue; Nerve Damage; Pain; Paralysis; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 50940902 ↗
• InjurySep 28, 2026Unexpected Therapeutic Results; Migration

  It was reported that the lead had migrated, and patient feels a burning sensation wrapping around to the front of his chest most specific on the left side. The device was no longer providing the optimal relief that it did previously. The patients medication was increased.

  Patient problems: Burning Sensation; Pain

  MAUDE report 50910629 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during an implant procedure, neuromonitoring detected sensory and motor variance in the patient's left quadriceps following placement of the passing elevator and paddle lead. In response, the physician increased the stimulation amplitude, after which the quadriceps responded normally. To avoid potentially compromising the patient's neurological outcome, the physician elected to abandon the procedure. No further patient complications were reported.

  Patient problems: Insufficient Information

  MAUDE report 50841699 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796895 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Spinal Cord Stimulation (SCS) device was explanted due to an unknown reason. The location of the replaced device is unknown. Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790114 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this Spinal Cord Stimulation (SCS) device was explanted due to an unknown reason. The location of the replaced device is unknown. Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unavailable per physicians' response.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789864 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50779974 ↗
• InjurySep 14, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient's Spinal Cord Stimulation (SCS) lead had migrated to the left side of midline, while the patient required right-side coverage. Due to the patient's anatomy, the physician was unable to revise the lead to the desired location. As a result, the Spinal Cord Stimulator (SCS) system was explanted. All explanted device components will not be returned per facility policy.

  Patient problems: Pain

  MAUDE report 50754715 ↗
• InjuryAug 18, 2026Unexpected Therapeutic Results; Migration

  It was reported that the lead migrated which was confirmed with imaging and the patient was also noted to be experiencing inadequate pain relief. The patient underwent paddle repositioning procedure. Patient had great coverage postoperatively.

  Patient problems: Pain

  MAUDE report 50308185 ↗
• InjuryAug 18, 2026Unexpected Therapeutic Results; Migration

  It was reported that the patient was experiencing inadequate pain relief. Imaging confirmed that the leads migrated. The patient underwent a lead replacement procedure. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295708 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent Spinal Cord Stimulation (SCS) lead explant procedure due to an unknown reason. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50290580 ↗
• InjuryAug 5, 2026Unexpected Therapeutic Results; Migration

  It was reported that the spinal cord stimulation (SCS) patient experienced inadequate stimulation due to lead migration and was only receiving one-sided stimulation. No patient complications were reported. The lead was located at the T7 anatomical level. The patient is doing good post operatively. The explanted lead was disposed of and was not returned for analysis.

  Patient problems: Pain

  MAUDE report 50144225 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a spinal cord stimulator (SCS) implant procedure and was initially reported to be recovering without complications. Two days following the implant procedure, the patient presented to the emergency department with thoracic pain and weakness/paralysis from the umbilical region downward. An MRI was performed and confirmed the presence of an epidural hematoma. The physician assessed the event as procedure related. The SCS system was explanted the following morning. The patient was discharged from the hospital on the same day as the explant procedure and transferred to a rehabilitation facility for recovery. At the time of reporting, the patient was undergoing rehabilitation, and a full recovery was anticipated. Attempts to obtain updated information regarding the patient's recovery status have been unsuccessful, as no response has been received from the rehabilitation center. The explanted devices will not be returned as they disposed by the medical facility.

  Patient problems: Hematoma; Muscle Weakness/Atrophy; Pain; Paralysis

  MAUDE report 50088888 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS WOUND WAS NOT HEALING WELL. THE PATIENT WAS EVALUATED AND PRESCRIBED ANTIBIOTICS FOR TREATMENT.

  Patient problems: Impaired Healing; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 25884325 ↗
• InjuryJul 17, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. PATIENT WAS EXPECTED TO FULLY RECOVER. THE EXPLANTED DEVICE WAS RETAINED BY CUSTOMER AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25864016 ↗
• MalfunctionJul 3, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WAS FRACTURED WITH HIGH IMPEDANCE READING. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEAD WAS REPLACED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25708344 ↗
• InjuryJul 3, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING AND EXPERIENCING LOSS OF STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25708333 ↗
• MalfunctionJun 26, 2026Fracture; High impedance

  IT WAS REPORTED THAT DURING IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT FOR MRI PURPOSES, THE PHYSICIAN NOTICED THAT THE FOURTH LEAD TAIL OF THE PADDLE LEAD WAS KINKED, WHEN THE LEAD WAS BEING REMOVED FROM THE BATTERY. THE PHYSICIAN WAS ABLE TO PLUG IT INTO THE NEW BATTERY HOWEVER THERE WAS AN IMPEDANCE OUT OF RANGE ON THAT LEAD. THE LEAD REMAINS IMPLANTED AND REPROGRAMMED AROUND CONTACTS. THE PATIENT HAD A GOOD COVERAGE OF PAINFUL AREAS. NO FURTHER ACTION REQUIRED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25640992 ↗
• InjuryJun 22, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT EVEN WHEN THE THERAPY WAS OFF, THE PATIENT EXPERIENCED ELECTRICAL SHOCKS IN THE BREASTS AND COULD NOT TAKE A DEEP BREATH UNTIL IT PASSES. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Dyspnea; Inappropriate Device Stimulation of Tissue

  MAUDE report 25587766 ↗
• InjuryMay 28, 2026Migration

  IT WAS REPORTED THAT THE LEADS MIGRATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325152 ↗
• MalfunctionMay 25, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF FEELING IN THE LEGS AND AN ELECTRICITY-LIKE SENSATION GOING THROUGH THE BODY WHEN ADJUSTING A NO FEEL THERAPY. IT WAS NOTED THAT THE PATIENT PREVIOUSLY HAD A LOWER BACK FUSION SURGERY AND THE SURGEON MAY HAVE MADE THE LEAD MIGRATE WHEN PUSHING THE MUSCLE AROUND.

  Patient problems: Numbness

  MAUDE report 25273379 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE SWELLING AROUND THEIR LEAD IMPLANT SITE.

  Patient problems: Swelling/ Edema

  MAUDE report 25263044 ↗
• InjuryMay 19, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEFT RIB PAIN. IMAGING CONFIRMED THAT THE LEAD MIGRATED. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WOULD NOT COUPLE WITH THE CHARGER. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT/REPOSITIONING PROCEDURE.

  Patient problems: Pain

  MAUDE report 25224942 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PRIOR REVISION PROCEDURE (MFR. REPORT NO.: 3006630150-2023-05050), THE PATIENTS SPINAL CORD STIMULATOR (SCS) PADDLE LEAD TAILS WERE CUT AND THE PADDLE LEAD REMAINED IMPLANTED. THE PATIENT SUBSEQUENTLY UNDERWENT A PROCEDURE DURING WHICH THE PADDLE LEAD WAS REMOVED AND A NEW SCS SYSTEM WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED AS IT WAS NOT RELEASED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186115 ↗
• InjuryMay 13, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIB OR TRUNK AREA WHENEVER STIMULATION WAS ON AND HAD INADEQUATE PAIN RELIEF. AN X-RAY WAS TAKEN AND THE RESULT SHOWED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD MIGRATED. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS UNSUCCESSFUL. THE PHYSICIAN ASSESSED THAT THE PADDLE LEAD HAD MIGRATED LATERALLY AND WAS SITTING ON A NERVE ROOT. THE PATIENT SUBSEQUENTLY UNDERWENT A PROCEDURE WHEREIN THE PADDLE LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE SCS PADDLE LEAD REMAINED IMPLANTED AND IN USE.

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 25166472 ↗

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-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-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-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-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-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.