SlimTip™ MN10450-90ARecalls & reported problems
Advanced Neuromodulation Systems, Inc. · DRG Implant Lead Kit · Class 3 · Implant
All models of SlimTip (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Advanced Neuromodulation Systems SlimTip lead kit is a dorsal root ganglion stimulator lead used for pain relief. Most of its 1,175 reports describe inadequate pain relief, with others mentioning leads that move, show high impedance or fracture. Recent reports describe leads removed and replaced, and one describes a partial lead left in the patient. The reports include 8 deaths and 1,161 injuries. No recalls name this device. Reports dropped from 102 in the previous 12 months to 59 in the last 12 months.
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
- 1,187
- Deaths reported
- 8
- Injuries reported
- 1,173
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,187 adverse event reports that list this exact device (DI 05415067027160), received between Jun 21, 2018 and Sep 29, 2026 — classified as 8 deaths, 1,173 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Migration” (297 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration297
- High impedance237
- Therapeutic or Diagnostic Output Failure200
- Adverse Event Without Identified Device or Use Problem194
- Fracture165
- Material Fragmentation45
- Use of Device Problem37
- Impedance Problem19
Patient problems
- Inadequate Pain Relief929
- Failure of Implant94
- No Clinical Signs, Symptoms or Conditions59
- No Consequences Or Impact To Patient45
- Foreign Body In Patient27
- Cerebrospinal Fluid Leakage23
- Undesired Nerve Stimulation19
- Device Embedded In Tissue or Plaque17
Recent adverse event reports
The 25 most recent of 1,187 reports, in the reporter's own words as published by the FDA.
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 23, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875220 ↗InjurySep 23, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875209 ↗InjurySep 23, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50875201 ↗InjurySep 23, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50875190 ↗InjurySep 23, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy. As such, surgical intervention took place wherein the entire system was explanted to address the issue. Date of explant is unknown.Investigation was unable to determine which of the leads is related to the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50873616 ↗InjurySep 21, 2026Impedance Problem
It was reported patient had impedances on the C7 lead that is impairing patient effective therapy. Surgical intervention may be pending to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50847511 ↗InjurySep 16, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50794132 ↗InjurySep 11, 2026Therapy Delivered to Incorrect Body Area
Patient problems: Inadequate Pain Relief; Undesired Nerve Stimulation
MAUDE report 50740551 ↗InjurySep 11, 2026Migration
Patient problems: Inadequate Pain Relief; Undesired Nerve Stimulation
MAUDE report 50740546 ↗InjuryAug 4, 2026Therapeutic or Diagnostic Output Failure; No Apparent Adverse Event
Additional information indicates the patient experienced new pain and not ineffective therapy; therefore, this device is no longer considered reportable.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 50128659 ↗InjuryJul 30, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy. Reprogramming has been unable to resolve the issue. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue. It is unknown which lead caused the ineffective therapy.
Patient problems: Inadequate Pain Relief
MAUDE report 50091210 ↗InjuryJul 29, 2026Therapeutic or Diagnostic Output Failure
It was reported patient experienced insufficient therapy with the system. Reprogramming was unable to resolve the issue. Patient underwent surgical intervention wherein the system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50074681 ↗InjuryJul 27, 2026Migration
It was reported patient's leads had migrated. Surgical intervention was undertaken wherein one lead was replaced and an additional lead was added. Due to patient's scar tissues, one lead was left implanted. Therapy was restored post-op.
Patient problems: Inadequate Pain Relief
MAUDE report 50011719 ↗InjuryJun 11, 2026Use of Device Problem
IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE ON (B)(6) 2026, [RELATED MANUFACTURER REFERENCE NUMBER: (B)(4), A PARTIAL LEAD WAS LEFT IMPLANTED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PARTIAL LEAD WAS EXPLANTED.
Patient problems: Foreign Body In Patient
MAUDE report 25476917 ↗InjuryJun 11, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Inadequate Pain Relief
MAUDE report 25473375 ↗InjuryJun 11, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Inadequate Pain Relief
MAUDE report 25473361 ↗InjuryJun 10, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE IN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 25452700 ↗InjuryJun 10, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 25452698 ↗InjuryMay 27, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AND HEATING SENSATION AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN 2023 WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS RESPONSIBLE FOR INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 25310926 ↗InjuryMay 13, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSE INEFFECTIVE STIMULATION.
Patient problems: Inadequate Pain Relief
MAUDE report 25164376 ↗InjuryMay 12, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ALL OF THE PATIENT'S LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE S1 AND L4 LEAD WERE REPLACED AND THE L5 LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25156004 ↗InjuryMay 12, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ALL OF THE PATIENT'S LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE S1 AND L4 LEAD WERE REPLACED AND THE L5 LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25156001 ↗InjuryMay 12, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ALL OF THE PATIENT'S LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE S1 AND L4 LEAD WERE REPLACED AND THE L5 LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25155998 ↗InjuryMay 12, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE ON (B)(6) 2026 [RELATED MANUFACTURER REFERENCE NUMBER:1627487-2026-01664, 1627487-2026-01665, AND 1627487-2026-02028], ONE OF THE LEADS FRACTURED AND A PORTION OF THE LEAD REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25153474 ↗
Other Dorsal root ganglion stimulator for pain relief devices
- SlimTip™ MN10450-50AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief7 deaths8,308 reports
- 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
- 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 14, 2026 · each report above links to its original FDA record
- 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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