Proclaim™ DRGRecalls & reported problems
St. Jude Medical, Inc. · Implantable Pulse Generator · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Medical Proclaim DRG pain stimulator has 2,157 reports, which include 8 deaths and 2,023 injuries. Many describe inadequate pain relief and pain at the implant site, and some describe the generator moving or flipping in its pocket. 2 recalls are open: one over generators reaching end of service sooner than labeled, and one over patients being unable to exit MRI mode.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,177
- Deaths reported
- 8
- Injuries reported
- 2,040
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2,177 adverse event reports that list this exact device (DI 05415067020215), received between Jun 14, 2018 and Sep 30, 2026 — classified as 8 deaths, 2,040 injuries, 129 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (237 reports).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 16, 2024Open, Classified
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Z-2367-2024 · Root cause: Vendor change control · FDA record ↗
- Jul 18, 2023Open, Classified
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Z-2509-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,152
- Wireless Communication Problem237
- Battery Problem156
- Therapeutic or Diagnostic Output Failure151
- Insufficient Device Problem Information148
- Migration129
- Premature Elective Replacement Indicator62
- High impedance32
Patient problems
- Inadequate Pain Relief670
- Implant Pain603
- Failure of Implant199
- Pain152
- Post Operative Wound Infection120
- No Clinical Signs, Symptoms or Conditions119
- Discomfort117
- Insufficient Information104
Recent adverse event reports
The 25 most recent of 2,177 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50949122 ↗InjurySep 30, 2026Temperature Problem
Patient problems: Burning Sensation
MAUDE report 50948643 ↗InjurySep 30, 2026Migration
It was reported that the patients IPG has tilted causing discomfort at the pocket site. Additionally, the patient states there is warmth at the pocket site. Surgical intervention may be taken at a later date to address the issue.
Patient problems: Implant Pain
MAUDE report 50948638 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient experienced discomfort at the IPG site. Surgical intervention was undertaken wherein the IPG were explanted and replaced, and new extensions were added to address the issue. Therapy was restored post-op.
Patient problems: Implant Pain
MAUDE report 50935431 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was explanted to address the issue.
Patient problems: Implant Pain
MAUDE report 50935107 ↗MalfunctionSep 29, 2026Wireless Communication Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50933961 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50924095 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced pain at the IPG site. As a result, the IPG was explanted and replaced to address the issue.
Patient problems: Implant Pain
MAUDE report 50917662 ↗InjurySep 25, 2026Insufficient Device Problem Information
It was reported that the patient experienced ineffective therapy following falls. Diagnostics revealed high impedances on the leads. It was also reported that the patient is scheduled for surgery for the IPG for an unknown reason. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Insufficient Information
MAUDE report 50893373 ↗InjurySep 24, 2026Wireless Communication Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50891647 ↗InjurySep 24, 2026Insufficient Device Problem Information
It was reported that the patient's system was explanted for an unknown reason. Further information is unavailable.
Patient problems: Insufficient Information
MAUDE report 50886713 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced pain at both IPG sites. As a result, surgical intervention was undertaken on both system were explanted to address the issue.
Patient problems: Implant Pain
MAUDE report 50877098 ↗InjurySep 23, 2026Premature Discharge of Battery
It was reported that the patient¿s IPG has reached its end of life. It is unknown if this occurred prematurely. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50868230 ↗InjurySep 22, 2026Wireless Communication Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50860663 ↗InjurySep 22, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50849926 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50847675 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Post Operative Wound Infection
MAUDE report 50834813 ↗InjurySep 17, 2026Insufficient Device Problem Information
It was reported that the patient had their system explanted on an unknown date for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50809244 ↗MalfunctionSep 16, 2026Wireless Communication Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50792276 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at the IPG site and was hospitalized. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue. The patient was administered both oral and IV antibiotics to address the issue.
Patient problems: Fluid Discharge; Wound Dehiscence
MAUDE report 50791629 ↗InjurySep 16, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting was unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50790783 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced and repositioned to address the issue.
Patient problems: Implant Pain
MAUDE report 50778058 ↗InjurySep 14, 2026Insufficient Device Problem Information
It was reported that the patient received a low battery warning. It is unknown if this occurred prematurely. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761171 ↗InjurySep 14, 2026High impedance
It was reported that the patient experienced ineffective therapy. Impedance check revealed high impedances on one of the leads. As such, surgical intervention took place on (b)(6) 2026 wherein the lead was removed from the IPG port and inserted into a different port to address the issue. Some of the impedances resolved. Effective therapy was restored post op.
Patient problems: Inadequate Pain Relief
MAUDE report 50755779 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50744165 ↗
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- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief81 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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