CoverEdge X 32Recalls & reported problems across all models

We found 2 models of CoverEdge X 32 by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 117 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2016 and Sep 30, 2026 — classified as 108 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (33 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CoverEdge X 32 problems

CoverEdge X 32 models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CoverEdge™ X 32 SC-8352-50

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  74 reports
• CoverEdge™ X 32 SC-8352-70

  STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  43 reports

Recent CoverEdge X 32 adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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