CoverEdge MRIRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls
- 0
We found 2 models of CoverEdge MRI by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2021 and Jul 21, 2026 — classified as 58 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (27 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
Reports received per month, all models
Most reported CoverEdge MRI problems
Device problems
- Migration27
- Adverse Event Without Identified Device or Use Problem26
- Unexpected Therapeutic Results23
- High impedance3
- Charging Problem1
- Fracture1
- Structural Problem1
Patient problems
- Pain25
- Inadequate Pain Relief9
- Bacterial Infection7
- No Clinical Signs, Symptoms or Conditions7
- Hematoma6
- Discomfort5
- Numbness5
- Paralysis5
CoverEdge MRI models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoverEdge™ MRI SC-8436-50Stimulator, spinal-cord, totally implanted for pain relief49 reports
- CoverEdge™ MRI SC-8436-70Stimulator, spinal-cord, totally implanted for pain relief11 reports
Recent CoverEdge MRI adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD WAS TORN OFF IN A VIOLENT CAR CRASH. IT WAS UNKNOWN IF CAR ACCIDENT WAS DEVICE RELATED. AS A RESULT, THE STIMULATION SETTING HAD TO BE INCREASED TO 100 TO ACHIEVE STIMULATION, WHICH CAUSED PAIN. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE.
Patient problems: Pain; Unspecified Tissue Injury
MAUDE report 25892716 ↗InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INCISION SITE THAT WRAPPED AROUND THE STOMACH FOLLOWING THE IMPLANT PROCEDURE. THE PHYSICIAN SUSPECTED EPIDURAL HEMATOMA, WHICH WAS BELIEVED TO BE NOT DIRECTLY RELATED TO THE DEVICE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.
Patient problems: Hematoma; Implant Pain
MAUDE report 25786564 ↗InjuryJun 23, 2026Migration
IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25589184 ↗InjuryMay 1, 2026Unexpected Therapeutic Results
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Patient problems: Pain
MAUDE report 25057719 ↗InjuryMar 31, 2026Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENTS PADDLE SPINAL CORD STIMULATOR (SCS) LEAD HAD MIGRATED. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF AND WAS GETTING STIMULATION IN NON-TARGET AREAS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Patient problems: Pain
MAUDE report 24747665 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS IN THE LEGS DUE TO THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD WAS COMPRESSING ON THE SPINAL CORD. THE PATIENT UNDERWENT A SCS PADDLE LEAD REPLACEMENT, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.
Patient problems: Muscle Weakness/Atrophy
MAUDE report 24571125 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A NEW EXCRUCIATING PAIN AT THE PADDLE LEAD INCISION SITE ALONG THE RIGHT SIDE OF THE BACK. IT WAS NOTED THAT THE PAIN WAS NOT DEVICE OR PROCEDURE RELATED AND THE ISSUE HAS BEEN RESOLVED. THE PATIENT WAS DOING WELL UPON FOLLOW-UP.
Patient problems: Implant Pain
MAUDE report 24339755 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REVISED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24073121 ↗InjurySep 18, 2025Migration; Migration
IT WAS REPORTED THAT THE SPINAL CORD STIMULATOR (SCS) PADDLE LEAD HAD MIGRATED OUT OF THE EPIDURAL SPACE DUE TO THE IMPLANTABLE PULSE GENERATOR (IPG) HAD SPUN IN THE POCKET CAUSING THE PATIENT TO EXPERIENCE PAIN. IT WAS NOTED THAT THE DEVICE MIGRATION WAS CONFIRMED THRU X-RAY IMAGING. THE PATIENT UNDERWENT A LEAD REPLACEMENT AND IPG REPOSITIONING PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.
Patient problems: Pain
MAUDE report 23089934 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS AT THE BOTTOM OF THE FEET. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) PADDLE LEAD EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED.
Patient problems: Numbness
MAUDE report 22879840 ↗InjuryAug 15, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT WAS NO LONGER GETTING ADEQUATE COVERAGE DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.
Patient problems: Pain
MAUDE report 22820101 ↗InjuryAug 14, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT COULD NO LONGER FEEL THE STIMULATION AFTER GOING FROM A STANDING TO SITTING POSITION. PROGRAM OPTIMIZATION WAS ATTEMPTED AND WAS NOT SUCCESSFUL. IMAGING WAS TAKEN WHICH CONFIRMED THAT THE PADDLE LEAD MIGRATED OUT OF THE EPIDURAL SPACE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE AND THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Pain
MAUDE report 22812676 ↗InjuryJun 19, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT HAS NEVER RECEIVED ADEQUATE PAIN RELIEF FROM HIS SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENTS SYSTEM WAS REPROGRAMMED MULTIPLE TIMES HOWEVER THE ISSUE PERSISTED. IMAGING WAS PERFORMED WHICH REVEALED SLIGHT MIGRATION OF THE SCS PADDLE LEAD. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT IS RECOVERING AS EXPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Patient problems: Pain
MAUDE report 22292333 ↗InjuryMay 26, 2025Unexpected Therapeutic Results; Migration; Unexpected Therapeutic Results; Migration
IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED WITH MEDICATION DUE TO AN INFECTION AT THE LEAD SITE. PATIENT HAD A LOT OF DRAINAGE, AND HER MIDLINE INCISION WAS SLIGHTLY OPEN. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED, AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION DUE TO A LEAD MIGRATION.
Patient problems: Bacterial Infection; Fluid Discharge; Wound Dehiscence
MAUDE report 22084996 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Patient problems: Unspecified Infection
MAUDE report 22044807 ↗
Other Boston Scientific Neuromodulation Corporation products
- Precision Spectra3 models · 11,348 reports
- Spectra WaveWriter4 models · 7,251 reports
- Precision17 models · 6,725 reports
- WaveWriter Alpha3 models · 4,356 reports · 1 recall
- Precision Montage MRI2 models · 4,332 reports
- Linear ST5 models · 4,068 reports
- Infinion CX2 models · 2,139 reports · 1 recall
- Superion5 models · 1,488 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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