SlimTip™ MN10450-50ARecalls & reported problems
Advanced Neuromodulation Systems, Inc. · DRG Implant Lead Kit · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This SlimTip dorsal root ganglion stimulator lead kit is an implanted device used for pain relief. Reports mostly describe leads moving out of place, high electrical resistance, and inadequate pain relief, with some patients needing surgery. There are 8,232 reports, including 7 deaths and 8,189 injuries. Reports fell to 749 in the last 12 months from 1,211 in the 12 months before. No recalls name this device.
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
- 8,308
- Deaths reported
- 7
- Injuries reported
- 8,266
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8,308 adverse event reports that list this exact device (DI 05415067027153), received between Jun 18, 2018 and Sep 30, 2026 — classified as 7 deaths, 8,266 injuries, 35 malfunctions.
The most frequently reported specific device problem is “Migration” (3,207 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, 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
Most reported problems
Device problems
- Migration3,207
- High impedance1,367
- Therapeutic or Diagnostic Output Failure1,272
- Adverse Event Without Identified Device or Use Problem1,065
- Fracture925
- Use of Device Problem268
- Material Fragmentation173
- Impedance Problem134
Patient problems
- Inadequate Pain Relief6,588
- Failure of Implant576
- No Clinical Signs, Symptoms or Conditions527
- Undesired Nerve Stimulation175
- No Consequences Or Impact To Patient170
- Foreign Body In Patient147
- Cerebrospinal Fluid Leakage129
- Device Embedded In Tissue or Plaque113
Recent adverse event reports
The 25 most recent of 8,308 reports, 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, 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 ↗InjurySep 28, 2026Migration
It was reported that the patient experienced ineffective therapy following a fall. X-ray imaging revealed migration of the S1-S2 lead. Trouble shooting revealed high impedances on the L5-S1 lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50918912 ↗InjurySep 27, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50909802 ↗InjurySep 27, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50909801 ↗InjurySep 25, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50903429 ↗InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Burning Sensation
MAUDE report 50902954 ↗InjurySep 25, 2026Migration
It was reported that following a fall the patient experienced ineffective therapy due to impedances on one lead and migration of the other. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50899834 ↗InjurySep 25, 2026Impedance Problem
It was reported that following a fall the patient experienced ineffective therapy due to impedances on one lead and migration of the other. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50899828 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection at the lead site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue. The patient was treated with oral antibiotics, IV antibiotics, and hospitalization to address the issue. It is unknown which lead is related to this issue.
Patient problems: Unspecified Infection
MAUDE report 50897612 ↗InjurySep 25, 2026High impedance
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: Inadequate Pain Relief
MAUDE report 50893374 ↗InjurySep 25, 2026High impedance
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: Inadequate Pain Relief
MAUDE report 50893372 ↗InjurySep 24, 2026Fracture
Patient problems: Inadequate Pain Relief
MAUDE report 50892116 ↗
Other Dorsal root ganglion stimulator for pain relief devices
- Proclaim™ DRGSt. Jude Medical, Inc. · Dorsal root ganglion stimulator for pain relief2 recalls8 deaths2,177 reports
- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief1,836 reports
- SlimTip™ MN10450-90AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief8 deaths1,187 reports
- Axium™ MN10200St. Jude Medical, Inc. · Dorsal root ganglion stimulator for pain relief484 reports
- Axium™ MN10450-90ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief443 reports
- SlimTip™ MN10350-50AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief3 deaths373 reports
- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief81 reports
- Axium™ MN10350-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief39 reports
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
- 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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