LamitrodeRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 516
- Deaths reported
- 0
- Injuries reported
- 514
- Recalls
- 0
We found 8 models of Lamitrode by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 516 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 30, 2026 — classified as 514 injuries, 2 malfunctions.
The most frequently reported specific device problem is “High impedance” (180 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Lamitrode problems
Device problems
- High impedance180
- Therapeutic or Diagnostic Output Failure100
- Adverse Event Without Identified Device or Use Problem98
- Migration47
- Fracture41
- Impedance Problem18
- Insufficient Device Problem Information18
- Inappropriate/Inadequate Shock/Stimulation14
Patient problems
- Inadequate Pain Relief380
- No Clinical Signs, Symptoms or Conditions34
- Failure of Implant29
- No Consequences Or Impact To Patient24
- Unspecified Infection15
- Pain14
- Undesired Nerve Stimulation13
- Post Operative Wound Infection9
Lamitrode models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lamitrode® 3286STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF332 reports
- Lamitrode® 3288STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF58 reports
- Lamitrode® 3240STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF46 reports
- Lamitrode® 3244STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF37 reports
- Lamitrode® 3262STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF20 reports
- Lamitrode® 3268STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF13 reports
- Lamitrode® 3246STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 reports
- Lamitrode® 3266STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF4 reports
Recent Lamitrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: Inadequate Pain Relief
MAUDE report 50947826 ↗InjuryMay 27, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE SYSTEM. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25309417 ↗InjuryApr 22, 2026High impedance; Impedance Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE CERVICAL LEAD. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24956931 ↗InjuryApr 3, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON THE LEAD. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24783543 ↗InjuryMar 30, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON THE LEADS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 24731825 ↗InjuryMar 30, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON THE LEADS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 24730246 ↗InjuryMar 15, 2026High impedance
IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24602004 ↗InjuryMar 15, 2026High impedance
IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24602003 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTION WAS SUSPECTED. AS A RESULT, SYSTEM WAS REMOVED IN THE SUMMER OF 2025 TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24532139 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTION WAS SUSPECTED. AS A RESULT, SYSTEM WAS REMOVED IN THE SUMMER OF 2025 TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24532134 ↗InjuryFeb 20, 2026High impedance
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PLACE THEIR SYSTEM INTO MRI MODE. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408002 ↗InjuryJan 16, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2026, WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 24102877 ↗InjuryJan 12, 2026High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEAD HAD HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. PATIENTS IPG WAS ALSO EXPLANTED AND REPLACED FOR AN UNKNOWN REASON.
Patient problems: Inadequate Pain Relief
MAUDE report 24048398 ↗InjuryDec 9, 2025High impedance; High impedance
ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23753440 ↗InjuryDec 5, 2025High impedance; High impedance
IT WAS REPORTED PATIENT WAS UNABLE TO SET THE IPG INTO MRI MODE DUE TO HIGH IMPEDANCE ON ONE OF THE LEADS, IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730328 ↗
Other Advanced Neuromodulation Systems, Inc. products
All Advanced Neuromodulation Systems, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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