CoverEdge™ 32 SC-8336-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 08714729832676), received between Dec 21, 2016 and Sep 25, 2026 — classified as 1 death, 362 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (127 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 386 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation; Migration

  It was reported that the patient experienced overstimulation from Spinal Cord Stimulator (SCS) device. It was also reported that the SCS lead had migrated and was causing pain. The patient underwent an SCS system explant procedure. No further information could be obtained despite good faith efforts.

  Patient problems: Pain

  MAUDE report 50897724 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the spinal cord stimulation (SCS) patient experienced pain, weakness, numbness, proprioceptive deficits, paresthesia, and urinary retention, accompanied by episodes of hypertensive crisis and tachycardia. The patient was referred to a local representative for reprogramming; however, it is unknown whether reprogramming was performed. The physician attempted nerve blocks, radiofrequency treatment, and additional SCS therapy to address the symptoms, but these interventions were unsuccessful. The patients symptoms were reported to progressively worsen over time. Subsequently, the patient underwent explantation of the lead and implantable pulse generator (IPG). Postoperatively, the patient demonstrated improvement and continued recovery of sensation, proprioception, and muscle control. It was further reported that the attending physician attributed the symptoms to a programming issue and did not pursue additional evaluation, prompting the patient to seek a second opinion. The patient subsequently developed permanent neurologic and autonomic dysfunction resulting in disability.

  Patient problems: Bladder Dysfunction; High Blood Pressure/ Hypertension; Inappropriate Device Stimulation of Tissue; Muscle Weakness/Atrophy; Numbness; Pain; Tachycardia

  MAUDE report 50859087 ↗
• InjurySep 10, 2026High impedance; Unexpected Therapeutic Results

  It was reported that the lead had high impedances and paresthesia could not be felt by the patient. The patient underwent a lead replacement procedure and was doing well postoperatively with successful programming done. The explanted device was not returned due to hospital policy.

  Patient problems: Pain

  MAUDE report 50718503 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING POST IMPLANT PROCEDURE, THE PATIENT HAD A DIFFICULT TIME WITH MOBILITY. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL WITH FULL FUNCTION AND MOVEMENT. NO FURTHER INFORMATION HAS BEEN OBTAINED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25895104 ↗
• InjuryJul 14, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHOCKING SENSATIONS AND MUSCLE SPASMS. THE PATIENT WAS ADMITTED TO THE HOSPITAL, BUT NO MEDICAL INTERVENTIONS WERE MADE FOR THE PATIENTS SPINAL CORD STIMULATOR (SCS) DEVICE. THE REASON FOR THE HOSPITALIZATION WAS UNKNOWN. AN SCS EXPLANT PROCEDURE WAS PLANNED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Inappropriate Device Stimulation of Tissue

  MAUDE report 25820446 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a rib stimulation. The patient underwent a lead replacement procedure and was doing well postoperatively. The explanted lead will not be returned per hospital policy.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25438743 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION WHICH CAUSED THE INCISION SITE TO OPEN AND THE LEADS EXPOSED OUT OF THE SKIN. THE PATIENT WAS PROVIDED WITH ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 25059615 ↗
• InjuryMar 30, 2026High impedance

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE SPINAL CORD STIMULATION (SCS) PADDLE LEAD WAS IMPLANTED THEN EXPLANTED DUE TO HIGH IMPEDANCES. A NEW PADDLE LEAD WAS THEN OPENED THEN IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716641 ↗
• InjuryMar 26, 2026Migration

  IT WAS REPORTED THAT THE PATIENT STIMULATION WAS NOT TARGETING THE RIGHT SPOT DUE TO SPINAL CORD STIMULATION (SCS) PADDLE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24700125 ↗
• InjuryMar 17, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENTS PADDLE LEAD WAS TOO LOW TO CAPTURE THE PAIN AREAS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN REPOSITIONED AND STRAIGHTENED THE PADDLE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE PADDLE LEAD REMAINS IMPLANTED IN THE PATIENT AND IN USE.

  Patient problems: Pain

  MAUDE report 24615562 ↗
• MalfunctionMar 16, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PROCEED WITH MAGNETIC RESONANCE IMAGING (MRI) DUE TO A LEAD FRACTURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604959 ↗
• InjuryFeb 18, 2026Unexpected Therapeutic Results; Migration

  THE SPINAL CORD STIMULATION (SCS) PATIENT REPORTED INADEQUATE PAIN RELIEF. DIAGNOSTIC X RAY IMAGING WAS PERFORMED AND CONFIRMED SLIGHT LEAD MIGRATION. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD AND SECURED TO THE FASCIA. POST OPERATIVELY, THE PATIENT IS RECOVERING. NO DEVICES WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 24384404 ↗
• InjuryJan 30, 2026Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: Pain

  MAUDE report 24221088 ↗
• InjuryJan 9, 2026High impedance

  IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. THE PATIENT IS PLEASED AND HAPPY POSTOPERATIVELY. REP WAS UNABLE TO KEEP THIS LEAD.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023263 ↗
• InjuryDec 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD OF THE PATIENT HAD IMPEDANCES ON MULTIPLE CONTACTS. X-RAY IMAGING CONFIRMED THAT THE SCS PADDLE LEAD HAD NOT MIGRATED OUT OF THE ORIGINAL POSITION. THE PATIENT UNDERWENT AN SCS PADDLE LEAD REVISION, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISPOSED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856817 ↗
• MalfunctionDec 12, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PADDLE LEAD EXPLANT AS IT WAS ACCIDENTALLY CUT DURING THE IMPLANTABLE PULSE GENERATOR (IPG) UPGRADE PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23795142 ↗
• InjuryDec 11, 2025Adverse 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 AN EXPLANT PROCEDURE DUE TO PARALYSIS IN THE LEGS FOLLOWING THE PROCEDURE. THE PATIENT'S SYMPTOMS INCLUDED LOSS OF FUNCTION AND SENSATION IN THE LOWER EXTREMITIES. ACCORDING TO THE PHYSICIAN'S ASSESSMENT, THE DEVICE CONTRIBUTED TO THESE COMPLICATIONS, AS THE PATIENT HAD FULL SENSATION PRIOR TO IMPLANTATION. POST-PROCEDURE, THE PATIENT CONTINUES TO EXPERIENCE LOWER EXTREMITY WEAKNESS AND NUMBNESS, THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE AND WAS SENT TO A REHABILITATION FACILITY. THE EXPLANTED DEVICES WILL NOT RETURN FOR ANALYSIS AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Muscle Weakness/Atrophy; Numbness; Paralysis

  MAUDE report 23782387 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE IN WHICH THE PATIENT WAS UNDER GENERAL ANESTHESIA, THE PATIENT EXPERIENCED LOSS OF HER MOTOR FUNCTIONS WITH NEUROMONITORING. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE. IT WAS ASSESSED THAT THE EVENT WAS NOT BELIEVED TO BE DEVICE RELATED, RATHER WAS DUE TO THE PATIENT'S ANATOMY. ONCE THE PROCEDURE WAS OVER, THE PATIENTS MOTOR FUNCTIONS RETURNED TO BASELINE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: Paralysis

  MAUDE report 23694166 ↗
• InjuryNov 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD OF THE PATIENT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23674038 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE, THE PATIENT WAS ADMITTED FOR STANDARD OVERNIGHT OBSERVATION. WITHIN A FEW HOURS OF THE PATIENT BEING MOVED TO INPATIENT UNIT, THE PATIENT REPORTED A LOSS OF FEELING/SENSATION FROM THE WAIST DOWN BUT COULD STILL MOVE THEIR LOWER EXTREMITIES. A SCAN WAS PERFORMED AND SHOWED A BLOOD CLOT UNDER THE SCS PADDLE LEAD. THE PATIENT WAS TAKEN BACK TO SURGERY WHERE THE SCS SYSTEM WAS REMOVED. THE PATIENT WAS RECOVERING IN POST-OP. THERE WAS NO ACTION FROM THE PHYSICIAN THAT IS BELIEVED WOULD HAVE CONTRIBUTED TO THE BLOOD CLOT FORMING UNDER THE SCS PADDLE LEAD. THE EXPLANTED DEVICES WERE NOT RETURNED BY THE MEDICAL FACILITY.

  Patient problems: Numbness; Thrombosis/Thrombus

  MAUDE report 23612285 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNDESIRED SENSATIONS IN THORACIC AREA WITH THE DEVICE ON OR OFF. THE CAUSE COULD NOT BE DETERMINED BY THE PHYSICIAN. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE, AND THE PATIENT WAS STABLE POSTOPERATIVELY. ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 23466395 ↗
• InjurySep 11, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE DUE TO LEAD MIGRATION. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034101 ↗
• InjurySep 9, 2025Migration; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENTS PADDLE LEAD MIGRATED FROM THE SECOND CERVICAL VERTEBRAL LEVEL TO THE TOP OF THE FIRST THORACIC VERTEBRAL LEVEL AND WAS PARTIALLY OUTSIDE OF THE EPIDURAL SPACE. BECAUSE OF THIS, STIMULATION WAS UNABLE TO BE ADJUSTED. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE PADDLE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD. THE NEW LEAD WAS IMPLANTED IN THE SAME LOCATION AS THE PREVIOUS LEADS ORIGINAL POSITION IN THE CERVICAL AREA. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED PADDLE LEAD WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000293 ↗
• InjurySep 5, 2025Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A LEAD FRACTURE WHICH WAS CONFIRMED WITH IMAGING. IT WAS ALSO NOTED THAT THE LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEAD EXTENSIONS WERE ADDED TO PREVENT THE LEAD FROM PULLING OUT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22980733 ↗
• InjuryAug 29, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD OF THE PATIENT HAD MIGRATED. THE PATIENT UNDERWENT A SCS REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO EXPERIENCED INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT IMAGING WAS DONE TO CONFIRM THE SCS PADDLE LEAD MIGRATION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ELECTIVELY REPLACED BY THE PHYSICIAN DUE TO THE IN-DEPTH NATURE OF THE PROCEDURE. THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

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

  MAUDE report 22929262 ↗

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-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-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-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.