SlimTipRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9,889
- Deaths reported
- 18
- Injuries reported
- 9,828
- Recalls
- 0
We found 4 models of SlimTip by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 9,889 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2018 and Sep 30, 2026 — classified as 18 deaths, 9,828 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Migration” (3,522 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 SlimTip problems
Device problems
- Migration3,522
- High impedance1,613
- Adverse Event Without Identified Device or Use Problem1,541
- Therapeutic or Diagnostic Output Failure1,477
- Fracture1,102
- Use of Device Problem315
- Material Fragmentation239
- Impedance Problem153
Patient problems
- Inadequate Pain Relief7,566
- Failure of Implant674
- No Clinical Signs, Symptoms or Conditions607
- No Consequences Or Impact To Patient285
- Cerebrospinal Fluid Leakage224
- Undesired Nerve Stimulation196
- Foreign Body In Patient177
- Device Embedded In Tissue or Plaque141
SlimTip models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SlimTip™ MN10450-50ADorsal root ganglion stimulator for pain relief7 deaths8,308 reports
- SlimTip™ MN10450-90ADorsal root ganglion stimulator for pain relief8 deaths1,187 reports
- SlimTip™ MN10350-50ADorsal root ganglion stimulator for pain relief3 deaths373 reports
- SlimTip™ MN10350-90ADorsal root ganglion stimulator for pain relief21 reports
Recent SlimTip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50954942 ↗InjurySep 30, 2026Use of Device Problem
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50950484 ↗InjurySep 29, 2026Migration
It was reported that the patient experienced ineffective therapy. Imaging revealed migration of one lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Inadequate Pain Relief
MAUDE report 50937993 ↗InjurySep 29, 2026Migration
It was reported that following a fall the patient experienced ineffective therapy due to one lead fracturing and the other lead migrating. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Inadequate Pain Relief
MAUDE report 50937766 ↗InjurySep 29, 2026Fracture
It was reported that following a fall the patient experienced ineffective therapy due to one lead fracturing and the other lead migrating. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Inadequate Pain Relief
MAUDE report 50937762 ↗InjurySep 29, 2026Fracture
It was reported that the patient experienced ineffective therapy following a fall. X-ray imaging revealed fracture of the left T12 lead and migration of the left L2 lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were explanted and replaced to address the issue. It is unknown which lead fractured, and which lead migrated.
Patient problems: Inadequate Pain Relief
MAUDE report 50937328 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced ineffective therapy due to high impedances on the leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Inadequate Pain Relief
MAUDE report 50936464 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced ineffective therapy due to high impedances on the leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Inadequate Pain Relief
MAUDE report 50936455 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced ineffective therapy. Diagnostics revealed high impedances on the right L1 lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50934220 ↗InjurySep 29, 2026Material Fragmentation
It was reported the patient experienced ineffective stimulation due to both leads migrating. Surgical intervention took place on (b)(6) 2026 wherein one lead was explanted and the second lead broke and partial remains implanted. Two new leads were implanted, and effective stimulation was established post-op. Surgical intervention may take place at a later date to address the partial lead that remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933048 ↗InjurySep 29, 2026Migration
It was reported the patient experienced ineffective stimulation due to both leads migrating. Surgical intervention took place on (b)(6) 2026 wherein one lead was explanted and the second lead broke and partial remains implanted. Two new leads were implanted, and effective stimulation was established post-op. Surgical intervention may take place at a later date to address the partial lead that remains implanted.
Patient problems: Inadequate Pain Relief
MAUDE report 50933025 ↗InjurySep 29, 2026Migration
It was reported the patient experienced ineffective stimulation due to both leads migrating. Surgical intervention took place on (b)(6) 2026 wherein one lead was explanted and the second lead broke and partial remains implanted. Two new leads were implanted, and effective stimulation was established post-op. Surgical intervention may take place at a later date to address the partial lead that remains implanted.
Patient problems: Inadequate Pain Relief
MAUDE report 50932992 ↗InjurySep 29, 2026Migration
It was reported that patient experienced ineffective therapy, patients leads had high and low impedances, imaging revealed patients 3rd lead migrated. Patient also experienced sharp sensation and heating at the IPG site. As a result, surgical intervention surgical intervention was undertaken on 21 September wherein IPG and leads were explanted and replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50931798 ↗InjurySep 28, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50926572 ↗InjurySep 28, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50918918 ↗
Other Advanced Neuromodulation Systems, Inc. products
All Advanced Neuromodulation Systems, Inc. devices →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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