Axium™ MN10450-90ARecalls & reported problems
Spinal Modulation, Inc. · 90cm SlimTip Implant Lead Kit · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Axium dorsal root ganglion stimulator lead is an implanted lead used to ease pain. The 444 reports mostly describe pain relief that fell short, along with leads showing high impedance, fractures or migration, and some describe surgery to replace the leads. There are 443 injuries, 1 malfunction and no deaths, and 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
- 443
- Deaths reported
- 0
- Injuries reported
- 442
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 05415067025548), received between Jun 12, 2018 and Jul 28, 2026 — classified as 442 injuries, 1 malfunction.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (81 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
- Adverse Event Without Identified Device or Use Problem117
- Therapeutic or Diagnostic Output Failure81
- Fracture74
- High impedance72
- Migration63
- Impedance Problem19
- Material Fragmentation18
- Disconnection16
Patient problems
- Inadequate Pain Relief352
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient16
- No Known Impact Or Consequence To Patient13
- Fall10
- Pain10
- Failure of Implant7
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 443 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Impedance Problem
It was reported that the patient experienced high impedances on the L2 lead. Reprogramming has been unable to resolve the issue. As a result, surgical intervention was undertaken to explant and replace the system. The L4 lead was explanted and replaced for an unknown reason.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060250 ↗InjuryMay 20, 2026High impedance
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN 2025 WHEREIN THE SYSTEM WAS EXPLANTED, AND THE LEADS WERE LEFT IMPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 25230653 ↗InjuryMay 20, 2026High impedance
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN 2025 WHEREIN THE SYSTEM WAS EXPLANTED, AND THE LEADS WERE LEFT IMPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 25230651 ↗InjuryMar 26, 2026Migration
IT WAS REPORTED THAT X-RAY IMAGING REVEALED MIGRATION OF THREE LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE S1 AND L5 LEADS WERE EXPLANTED AND REPLACED, AND THE L3 LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698390 ↗InjuryMar 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED AND TWO S1 LEADS WERE ADDED FOR EXISTING PAIN. EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24552443 ↗InjuryMar 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED AND TWO S1 LEADS WERE ADDED FOR EXISTING PAIN. EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24552419 ↗InjuryNov 21, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING AN UNRELATED PROCEDURE WHERE THE SYSTEM WAS BEING EXPLANTED, ONE LEAD WAS CUT AND LEFT IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 23624370 ↗InjuryOct 21, 2025Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. X-RAY IMAGING REVEALED THAT THE L4 LEADS WERE FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN ONLY A PORTION OF THE LEFT LEAD WAS ABLE TO BE EXPLANTED, AND A NEW LEAD WAS PLACED ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 23345224 ↗InjuryOct 21, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE ON (B)(6) 2025, THE PHYSICIAN WAS UNABLE TO EXPLANT THE FRACTURED LEFT L4 LEAD COMPLETELY, 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 23345218 ↗InjurySep 9, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING STIMULATION ACCOMPANIED BY MUSCLE SPASMS. DIAGNOSTICS REVEALED THE LEFT L4 LEAD HAS ALL HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Cramp(s) /Muscle Spasm(s); Undesired Nerve Stimulation
MAUDE report 23000281 ↗InjuryJun 19, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A LEAD REPLACEMENT PROCEDURE ON (B)(6) 2025 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-02961], THE PATIENT WAS EXPERIENCING A MOTOR RESPONSE IN THEIR LEGS WHILE THE IPG WAS IN SURGERY MODE. THE IPG WAS EXPLANTED AND REPLACED DURING THE PROCEDURE TO ADDRESS THE ISSUE. THE S1 LEAD FRAGMENTED AND WAS LEFT PARTIALLY IMPLANTED IN THE PATIENT AND SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 22290131 ↗InjuryJun 16, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FROM THE S1 LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN (B)(6) 2025 WHEREIN THE S1 LEAD FRAGMENTED AND WAS LEFT PARTIALLY IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient; Inadequate Pain Relief
MAUDE report 22216038 ↗InjuryJun 13, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT DUE TO A RECENT FALL THE PATIENT BEGAN EXPERIENCING INEFFECTIVE STIMULATION WITH DRG LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22206677 ↗InjuryJun 13, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT DUE TO A RECENT FALL THE PATIENT BEGAN EXPERIENCING INEFFECTIVE STIMULATION WITH DRG LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22206676 ↗InjuryJun 13, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT DUE TO A RECENT FALL THE PATIENT BEGAN EXPERIENCING INEFFECTIVE STIMULATION WITH DRG LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22206675 ↗InjuryApr 4, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE DRG SYSTEM. AS A RESULT, SURGICAL INTERVENTION ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.
Patient problems: Inadequate Pain Relief
MAUDE report 21773309 ↗InjuryFeb 19, 2025Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE FRACTURED LEADS WERE UNABLE TO BE EXPLANTED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21407448 ↗InjuryFeb 19, 2025Fracture; Fracture
ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE FRACTURED LEADS WERE UNABLE TO BE EXPLANTED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21407376 ↗InjuryDec 26, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTIC TESTING REVEALED HIGH IMPEDANCES ON ALL LEADS, AS WELL AS S1 LEAD MIGRATION. AS A RESULT, THE ENTIRE SYSTEM WAS EXPLANTED VIA SURGICAL INTERVENTION ON (B)(6) 2024.
Patient problems: Inadequate Pain Relief
MAUDE report 21019302 ↗InjuryOct 23, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH BOTH THE SCS AND DRG SYSTEMS. IT WAS NOTED THAT X-RAYS SHOWED THAT ALL 4 DRG LEADS MIGRATED. ADDITIONALLY, THE SCS IPG BECAME INOPERABLE AND WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE DRG SYSTEM WAS EXPLANTED. BOTH SCS LEADS WERE REPOSITIONED AND PULLED DOWN TO THE TOP OF T10 AND THE SCS IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED TO THE SCS SYSTEM.
Patient problems: Inadequate Pain Relief
MAUDE report 20518286 ↗InjuryOct 23, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH BOTH THE SCS AND DRG SYSTEMS. IT WAS NOTED THAT X-RAYS SHOWED THAT ALL 4 DRG LEADS MIGRATED. ADDITIONALLY, THE SCS IPG BECAME INOPERABLE AND WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE DRG SYSTEM WAS EXPLANTED. BOTH SCS LEADS WERE REPOSITIONED AND PULLED DOWN TO THE TOP OF T10 AND THE SCS IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED TO THE SCS SYSTEM.
Patient problems: Inadequate Pain Relief
MAUDE report 20518146 ↗InjuryOct 23, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH BOTH THE SCS AND DRG SYSTEMS. IT WAS NOTED THAT X-RAYS SHOWED THAT ALL 4 DRG LEADS MIGRATED. ADDITIONALLY, THE SCS IPG BECAME INOPERABLE AND WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON 04OCT2024 WHEREIN THE DRG SYSTEM WAS EXPLANTED. BOTH SCS LEADS WERE REPOSITIONED AND PULLED DOWN TO THE TOP OF T10 AND THE SCS IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED TO THE SCS SYSTEM.
Patient problems: Inadequate Pain Relief
MAUDE report 20518094 ↗InjuryOct 23, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH BOTH THE SCS AND DRG SYSTEMS. IT WAS NOTED THAT X-RAYS SHOWED THAT ALL 4 DRG LEADS MIGRATED. ADDITIONALLY, THE SCS IPG BECAME INOPERABLE AND WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE DRG SYSTEM WAS EXPLANTED. BOTH SCS LEADS WERE REPOSITIONED AND PULLED DOWN TO THE TOP OF T10 AND THE SCS IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED TO THE SCS SYSTEM.
Patient problems: Inadequate Pain Relief
MAUDE report 20517990 ↗InjuryAug 7, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN PATIENTS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 19932591 ↗InjuryJul 25, 2024Migration; Migration
IT WAS REPORTED THAT UNDER FLURO PATIENTS LEAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 19834299 ↗
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
- 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
- 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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