Axium™ MN10450-50A (UDI 05415067025531)Recalls & reported problems
Spinal Modulation, Inc. · 50cm SlimTip Implant Lead Kit · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Spinal Modulation Axium lead, used with a nerve stimulator for pain relief, has 1,827 adverse event reports on record, with no deaths and 1,825 injuries. Most reports describe the pain relief becoming ineffective, with leads moving out of place, fracturing, or showing high electrical resistance, and some of these led to surgery to replace them. Some reports describe part of a lead being left in the patient during removal. 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
- 1,836
- Deaths reported
- 0
- Injuries reported
- 1,834
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,836 adverse event reports that list this exact device (DI 05415067025531), received between Jun 11, 2018 and Sep 28, 2026 — classified as 1,834 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (358 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 Problem678
- Migration358
- High impedance296
- Therapeutic or Diagnostic Output Failure242
- Fracture195
- Impedance Problem44
- Material Fragmentation35
- Insufficient Device Problem Information34
Patient problems
- Inadequate Pain Relief1,519
- No Consequences Or Impact To Patient87
- No Clinical Signs, Symptoms or Conditions73
- Undesired Nerve Stimulation31
- Fall29
- No Known Impact Or Consequence To Patient28
- Failure of Implant27
- Pain22
Recent adverse event reports
The 25 most recent of 1,836 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Migration
It was reported that the patient experienced ineffective therapy. X-ray imaging revealed migration of two leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the Left L4-L5 was explanted, and surgical intervention was undertaken on (b)(6) 2026 wherein the Left L3-L4 was explanted and replaced to address the issue. It is unknown which leads migrated.
Patient problems: Inadequate Pain Relief
MAUDE report 50923567 ↗InjurySep 28, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50923564 ↗InjurySep 14, 2026Migration
It was reported that the patient had ineffective therapy. X-ray imaging revealed migration of leads. As a result, the entire system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50757001 ↗InjurySep 14, 2026Migration
It was reported that the patient had ineffective therapy. X-ray imaging revealed migration of leads. As a result, the entire system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50757000 ↗InjurySep 14, 2026Migration
It was reported that the patient had ineffective therapy. X-ray imaging reveled migration of leads. As a result, the entire system was explanted to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50756995 ↗InjurySep 14, 2026Material Fragmentation
It was reported that during a lead revision on 21AUG2026 (Related Manufacturer Reference Number:1627487-2026-01395) a portion of lead was left implanted. As such, surgical intervention may take place at a later date to address the issue.Investigation was unable to determine which of the leads is the left lead.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755119 ↗InjuryAug 20, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy. As a result, surgical intervention may be undertaken to address the issue. It is unknown which lead is liable.
Patient problems: Inadequate Pain Relief
MAUDE report 50358570 ↗InjuryJul 30, 2026High impedance
It was reported that the patient experienced ineffective therapy following a fall. Troubleshooting revealed high impedances on all leads. As a result, surgical intervention was undertaken on 16JUL2026 wherein leads were explanted and replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50089819 ↗InjuryJul 30, 2026High impedance
It was reported that the patient experienced ineffective therapy following a fall. Troubleshooting revealed high impedances on all leads. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein leads were explanted and replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50089818 ↗InjuryJul 27, 2026Migration
It was reported that the patient experienced ineffective therapy. Diagnostic testing revealed high impedances on three leads, and X-ray imaging showed migration of the left L5 lead. As a result, surgical intervention was performed on (b)(6) 2026. During the procedure, it was observed that the leads had become disconnected from the IPG because they had not been properly tightened into the device. Consequently, the IPG and the migrated lead were replaced, while the remaining original leads were tightened into the new IPG to address the issue. Following the procedure, the patient continued to experience ineffective therapy because the leads that were not replaced were not providing stimulation. Therefore, additional surgical intervention may be undertaken to address the remaining issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50047162 ↗InjuryJul 27, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy. Diagnostic testing revealed high impedances on three leads, and X-ray imaging showed migration of the left L5 lead. As a result, surgical intervention was performed on 06JUL2026. During the procedure, it was observed that the leads had become disconnected from the IPG because they had not been properly tightened into the device. Consequently, the IPG and the migrated lead were replaced, while the remaining original leads were tightened into the new IPG to address the issue. Following the procedure, the patient continued to experience ineffective therapy because the leads that were not replaced were not providing stimulation. Therefore, additional surgical intervention may be undertaken to address the remaining issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50047077 ↗InjuryJun 29, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF THE L4 AND L5 LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 25652075 ↗InjuryJun 29, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF THE L4 AND L5 LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 25652018 ↗InjuryMay 27, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH L5 AND S1 LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN BOTH LEADS WERE EXPLANTED AND THE S1 LEAD WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 25310620 ↗InjuryMay 12, 2026Use of Device Problem
IT WAS REPORTED THAT DURING A DRG SYSTEM EXPLANT SURGERY, A PORTION OF A LEAD WAS LEFT IMPLANTED IN THE PATIENT. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD WAS LEFT IMPLANTED.
Patient problems: Foreign Body In Patient
MAUDE report 25149061 ↗InjuryApr 30, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON ONE OF THE PATIENT'S LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN AN ADDITIONAL LEAD WAS ADDED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAD HIGH IMPEDANCES.
Patient problems: Inadequate Pain Relief
MAUDE report 25053448 ↗InjuryApr 23, 2026Use of Device Problem
IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE ON (B)(6) 2026 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-01991] THE L5 LEAD WAS PARTIALLY REMOVED, AND A PORTION OF THE LEAD WAS LEFT IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24966765 ↗InjuryApr 23, 2026High impedance
IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON THE L5 LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS PARTIALLY REMOVED, AND A PORTION OF THE LEAD WAS LEFT IN THE PATIENT [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2026-01992].
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966763 ↗InjuryApr 6, 2026Fracture
IT WAS REPORTED THAT IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON THE LEAD. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. AFTER THE EXPLANT, THE LEAD APPEARED TO BE FRACTURED. REPORTEDLY, EFFECTIVE THERAPY WAS CONFIRMED POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24794002 ↗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 24698384 ↗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 24698376 ↗InjuryMar 24, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON ALL CONTACTS OF THE LEFT LEAD. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS IS THE LEFT LEAD.
Patient problems: Inadequate Pain Relief
MAUDE report 24681415 ↗InjuryMar 20, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN 2016 WHEREIN THE 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 24654231 ↗InjuryMar 10, 2026Fracture
IT WAS REPORTED THAT THE PATIENT'S L5 LEAD WAS FRACTURED, AND THE L3 LEAD HAD LOW IMPENDENCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 24560700 ↗InjuryMar 6, 2026Fracture
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY AFTER TAKING A FALL. X-RAY IMAGING REVEALED THAT ALL THE LEADS MIGRATED AND WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 24536427 ↗
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
- 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 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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