Axium™ MN10450-50A (UDI 05415067027337)Recalls & reported problems
Spinal Modulation, Inc. · 50cm SlimTip™ Implant Lead Kit · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Axium SlimTip implant lead kit is a dorsal root ganglion stimulator lead used for pain relief. Its 79 reports, with no deaths and 79 injuries, mostly describe pain relief that is not working well, with X-rays showing the leads have moved out of place. Other reports describe leads that broke during removal surgery, leaving a piece in the body, and some patients needed surgery to replace the leads. 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
- 81
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05415067027337), received between Feb 17, 2021 and Sep 29, 2026 — classified as 81 injuries.
The most frequently reported specific device problem is “Migration” (18 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration18
- High impedance17
- Therapeutic or Diagnostic Output Failure14
- Fracture12
- Material Fragmentation5
- Use of Device Problem4
- Disconnection3
- Impedance Problem3
Patient problems
- Inadequate Pain Relief68
- Failure of Implant8
- No Clinical Signs, Symptoms or Conditions7
- Device Embedded In Tissue or Plaque3
- Undesired Nerve Stimulation2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
It was reported that the patient experienced ineffective therapy due to lead fracture confirmed via x-ray. As a result, surgical intervention was undertaken in (b)(6) 2025 wherein the system was explanted to address the issue. It is unknown which lead was fractured.
Patient problems: Inadequate Pain Relief
MAUDE report 50937691 ↗InjurySep 9, 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 caused the ineffective therapy.
Patient problems: Inadequate Pain Relief
MAUDE report 50697993 ↗InjuryDec 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)6) 2026, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE LEADS. THERAPY WAS RESTORED POSTOPERATIVELY.
Patient problems: Undesired Nerve Stimulation
MAUDE report 23831697 ↗InjuryDec 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THE LEADS. THERAPY WAS RESTORED POSTOPERATIVELY.
Patient problems: Undesired Nerve Stimulation
MAUDE report 23831694 ↗InjuryNov 5, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23482058 ↗InjuryNov 5, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23482052 ↗InjuryAug 25, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22891043 ↗InjuryAug 25, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22890946 ↗InjuryMay 30, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE ON (B)(6) 2025 (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-02670) THE LEADS WERE SNAPPED. AS SUCH, ONLY A PORTION OF THE LEADS WERE REMOVED AND THE REMAINING FRAGMENT OF THE LEADS REMAINS IMPLANTED. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO REMOVE THE REMAINING PORTION OF THE LEADS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22118938 ↗InjuryMay 30, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE ON (B)(6) 2025 (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-02670) THE LEADS WERE SNAPPED. AS SUCH, ONLY A PORTION OF THE LEADS WERE REMOVED AND THE REMAINING FRAGMENT OF THE LEADS REMAINS IMPLANTED. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO REMOVE THE REMAINING PORTION OF THE LEADS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22118930 ↗InjuryMay 30, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 TO EXPLANT THE ENTIRE SYSTEM. DURING THE EXPLANT PROCEDURE, THE IPG WAS EXPLANTED AND THE LEADS WERE SNAPPED. AS SUCH, ONLY A PORTION OF THE LEADS WERE REMOVED AND THE REMAINING FRAGMENT OF THE LEADS REMAINS IMPLANTED (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-02672 AND 1627487-2025-02673). INVESTIGATION WAS UNABLE TO DETERMINE WHICH IF THE LEADS ATTRIBUTED TO THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22118921 ↗InjuryApr 25, 2024High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. LEAD DIAGNOSTICS SHOWED THAT THE RIGHT S1 LEAD HAD HIGH IMPEDANCES ON ALL CONTACTS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE S1 LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 19188165 ↗InjuryJan 4, 2024Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2024-00085. IT WAS REPORTED THE PATIENT'S LEADS HAD MIGRATED. AS SUCH, SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18445199 ↗InjuryJan 4, 2024Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2024-00086. IT WAS REPORTED THE PATIENT'S LEADS HAD MIGRATED. AS SUCH, SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18445167 ↗InjuryDec 25, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER 1627487-2023-06090 AND 1627487-2023-06089 IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED THAT THE LEAD HAD MULTIPLE CONTACTS WITH HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 18390554 ↗InjuryDec 25, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER 1627487-2023-06089 AND 1627487-2023-06091. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED THAT THE LEAD HAD MULTIPLE CONTACTS WITH HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 18390553 ↗InjuryDec 25, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER 1627487-2023-06090 AND 1627487-2023-06091.IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED THAT THE LEAD HAD MULTIPLE CONTACTS WITH HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 18390552 ↗InjuryDec 24, 2023Impedance Problem; Impedance Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THE ENTIRE DRG SYSTEM WAS EXPLANTED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 18390043 ↗InjuryNov 21, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT'S S1 LEAD FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 18188248 ↗InjuryOct 10, 2023Fracture; Fracture
ADDITIONAL INFORMATION INDICATED THAT SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 17908668 ↗InjurySep 21, 2023Migration; Migration
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-04523. IT WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED OUT OF THE SPINE INTO THE BATTERY POCKET. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 17795924 ↗InjurySep 21, 2023Migration; Migration
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-04522. IT WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED OUT OF THE SPINE INTO THE BATTERY POCKET. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 17794759 ↗InjurySep 14, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER 1627487-2023-04362. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED THAT 2 OF 3 LEADS HAD MULTIPLE CONTACTS WITH HIGH IMPEDANCE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 17746506 ↗InjurySep 14, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER 1627487-2023-04363. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS INDICATED THAT 2 OF 3 LEADS HAD MULTIPLE CONTACTS WITH HIGH IMPEDANCE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 17746500 ↗InjurySep 11, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE ON (B)(6) 2023, (MANUFACTURER REPORT NUMBER: 1627487-2023-04178), THE PATIENT'S LEFT S1 LEAD HAD FRACTURED DURING AN ATTEMPT TO EXPLANT IT AND FOUR CONTACTS WERE ABANDONED IN THE SACRAL EPIDURAL SPACE. NO FURTHER INTERVENTION IS PLANNED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17726673 ↗
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
- 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™ 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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