CoverEdge 32Recalls & 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
- 1,188
- Deaths reported
- 1
- Injuries reported
- 1,113
- Recalls
- 0
We found 2 models of CoverEdge 32 by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 1,188 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Sep 29, 2026 — classified as 1 death, 1,113 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Migration” (432 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 32 problems
Device problems
- Adverse Event Without Identified Device or Use Problem455
- Migration432
- Unexpected Therapeutic Results424
- High impedance116
- Fracture60
- Device Dislodged or Dislocated22
- Inappropriate/Inadequate Shock/Stimulation20
- Migration or Expulsion of Device18
Patient problems
- No Code Available287
- Pain271
- No Clinical Signs, Symptoms or Conditions229
- Inadequate Pain Relief117
- Hematoma90
- Paralysis85
- Bacterial Infection78
- Undesired Nerve Stimulation56
CoverEdge 32 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CoverEdge™ 32 SC-8336-50STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF802 reports
- CoverEdge™ 32 SC-8336-70STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death386 reports
Recent CoverEdge 32 adverse event reports
The 15 most recent reports across all models, 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 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 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 ↗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 ↗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 ↗
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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