Spectra WaveWriterRecalls & reported problems across all models
Boston Scientific Neuromodulation Corporation · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7,251
- Deaths reported
- 31
- Injuries reported
- 7,211
- Recalls
- 0
We found 4 models of Spectra WaveWriter by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 7,251 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2017 and Sep 30, 2026 — classified as 31 deaths, 7,211 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (2,337 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 Spectra WaveWriter problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,862
- Charging Problem2,337
- Unexpected Therapeutic Results1,985
- Migration473
- Defective Device236
- Delayed Charge Time167
- High impedance144
- Inappropriate/Inadequate Shock/Stimulation129
Patient problems
- No Clinical Signs, Symptoms or Conditions2,743
- No Code Available1,662
- Pain1,616
- Discomfort617
- Inadequate Pain Relief568
- Unspecified Infection380
- Implant Pain368
- Bacterial Infection329
Spectra WaveWriter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spectra WaveWriter™ SC-1160STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF31 deaths7,221 reports
- Spectra WaveWriter™ SC-1060-BSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF26 reports
- Spectra WaveWriter™ SC-5160STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Spectra WaveWriter™ SC-5160RSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
Recent Spectra WaveWriter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Charging Problem
It was reported that the patient's Implantable Pulse Generator (IPG) was not holding a charge. The patient underwent a procedure wherein the IPG was replaced with an MRI compatible device and that the was doing well postoperatively. The explanted IPG was retained by the medical facility and will not be returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945099 ↗InjurySep 30, 2026Unexpected Therapeutic Results
It was reported that the patients spinal cord stimulator (SCS) was not providing stimulation. All device components were explanted. No further information has been obtained despite good faith efforts.
Patient problems: Pain
MAUDE report 50944565 ↗InjurySep 30, 2026Unexpected Therapeutic Results; Insufficient Device Problem Information
It was reported that the patient experienced an inadequate stimulation despite multiple program optimization. The patient underwent an Implantable Pulse Generator (IPG) explant procedure. No further information has been obtained.
Patient problems: Pain
MAUDE report 50943332 ↗InjurySep 30, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941569 ↗InjurySep 29, 2026Unexpected Therapeutic Results
It was reported that the spinal cord stimulation (SCS) patient underwent explant of the system due to patient dissatisfaction with therapy and persistent implantable pulse generator (IPG) pocket pain. No patient complications were reported. The onset date of the issue was unavailable. The patient underwent explant of the system and was reported to be doing well postoperatively. The explanted devices were disposed of per facility policy and were not returned for analysis.
Patient problems: Pain
MAUDE report 50934988 ↗InjurySep 29, 2026Unexpected Therapeutic Results
Patient problems: Back pain
MAUDE report 50932968 ↗InjurySep 29, 2026Unexpected Therapeutic Results
It was reported that the patients Implantable Pulse Generator (IPG) was experiencing loss of stimulation and pain the Leads had high impedances. The patient underwent an Implantable Pulse Generator (IPG) replacement procedure and was doing well postoperatively. The explanted device was not returned.
Patient problems: Implant Pain
MAUDE report 50929783 ↗InjurySep 28, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915669 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50915666 ↗InjurySep 28, 2026Charging Problem
It was reported that the patient was having difficulty charging the Implantable Pulse Generator (IPG). The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG was discarded by the medical facility and will not be returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913814 ↗InjurySep 26, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908351 ↗DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the spinal cord stimulation (SCS) patient passed away. The cause of death is not believed to be related to stimulation; however, it remains unconfirmed. No further information has been obtained.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902771 ↗InjurySep 25, 2026Unexpected Therapeutic Results
Patient problems: Pain
MAUDE report 50902701 ↗InjurySep 25, 2026Unexpected Therapeutic Results
It was reported that the patient experienced inadequate pain relief. It was also stated that the device was causing more pain. The patient underwent Implantable Pulse Generator (IPG) explant procedure.
Patient problems: Pain
MAUDE report 50898596 ↗InjurySep 25, 2026Unexpected Therapeutic Results
It was reported that the patient was experiencing inadequate stimulation and worsening pain. It was also stated that the patient felt numbness and tingling in the legs. The patient underwent a procedure wherein the IPG was replaced with an MRI compatible device. The patient was doing well postoperatively.
Patient problems: Numbness; Pain; Paresthesia
MAUDE report 50897599 ↗
Other Boston Scientific Neuromodulation Corporation products
- Precision Spectra3 models · 11,348 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
- Infinion 165 models · 1,550 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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