Precision Montage 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
- 4,332
- Deaths reported
- 22
- Injuries reported
- 4,274
- Recalls
- 0
We found 2 models of Precision Montage MRI by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 4,332 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 22 deaths, 4,274 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (1,411 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 Precision Montage MRI problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,718
- Charging Problem1,411
- Unexpected Therapeutic Results1,081
- Migration236
- Delayed Charge Time138
- Defective Device135
- Inappropriate/Inadequate Shock/Stimulation78
- Wireless Communication Problem78
Patient problems
- No Clinical Signs, Symptoms or Conditions1,699
- Pain958
- No Code Available791
- Discomfort390
- Inadequate Pain Relief321
- Bacterial Infection205
- Unspecified Infection185
- Implant Pain134
Precision Montage MRI models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Precision™ Montage™ MRI SC-1200STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF22 deaths4,316 reports
- Precision Montage ™ MRI SC-1210BSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF16 reports
Recent Precision Montage MRI 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 was experiencing pain at the IPG and the patient was unable to charge the IPG. The patient underwent a procedure wherein the implantable pulse generator (IPG) and spinal cord stimulator (SCS) leads were replaced with an MRI compatible device. The patient was doing well postoperatively and the explanted devices were retained by the medical facility and will not be returned.
Patient problems: Implant Pain
MAUDE report 50941952 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934469 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932631 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was experiencing pain at the Implantable Pulse Generator (IPG) site. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted device was not returned.
Patient problems: Implant Pain
MAUDE report 50929785 ↗InjurySep 28, 2026Charging Problem
It was reported that the spinal cord stimulation (SCS) patient underwent an implantable pulse generator (IPG) replacement due to difficulty charging. Reeducation was attempted. No patient complications were reported. The patient was reported to be alert and oriented postoperatively with no complications. The explanted device was not returned for analysis due to hospital policy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920305 ↗DeathSep 28, 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 50918191 ↗InjurySep 28, 2026Charging Problem
It was reported that the patients Implantable Pulse Generator (IPG) was not holding a charge. The patient underwent an IPG replacement procedure and was doing well postoperatively. The explanted IPG will not be returned per hospital policy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910677 ↗InjurySep 28, 2026Charging Problem
It was reported that the patients Implantable Pulse Generator (IPG) was not holding a charge and the patient had difficulty charging it. The patient underwent an IPG replacement procedure and was doing well postoperatively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910625 ↗MalfunctionSep 25, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50905892 ↗InjurySep 25, 2026Wireless Communication Problem
It was reported that the patient was experiencing inability to connect to Implantable Pulse Generator (IPG). The patient underwent Implantable Pulse Generator (IPG) replacement procedure. Patient was doing well postoperatively. Unable to return product due to hospital policy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898542 ↗InjurySep 25, 2026Charging Problem
It was reported that this Spinal Cord Stimulation (SCS) patient experienced charging difficulties with his implantable pulse generator (IPG), to address this the patient underwent a revision procedure where in the IPG was explanted and replace. Post operatively the patient is doing great. In accordance with facility policy the explanted device was disposed of and will not be returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897784 ↗InjurySep 24, 2026Unexpected Therapeutic Results
Patient problems: Burning Sensation; Pain
MAUDE report 50892400 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent an Implantable Pulse Generator (IPG) replacement procedure due to an unknown reason. The patient was doing well postoperatively. Explanted device was not returned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878503 ↗InjurySep 23, 2026Charging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876370 ↗InjurySep 23, 2026Charging Problem; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862960 ↗
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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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