Lamitrode TripoleRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 331
- Deaths reported
- 1
- Injuries reported
- 329
- Recalls
- 0
We found 2 models of Lamitrode Tripole by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 331 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Sep 29, 2026 — classified as 1 death, 329 injuries, 1 malfunction.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (98 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 Tripole problems
Device problems
- Therapeutic or Diagnostic Output Failure98
- High impedance66
- Adverse Event Without Identified Device or Use Problem53
- Migration34
- Fracture14
- Inappropriate/Inadequate Shock/Stimulation14
- Insufficient Device Problem Information14
- Use of Device Problem14
Patient problems
- Inadequate Pain Relief217
- No Clinical Signs, Symptoms or Conditions33
- Failure of Implant22
- Undesired Nerve Stimulation19
- No Consequences Or Impact To Patient12
- Implant Pain9
- Hematoma8
- Post Operative Wound Infection6
Lamitrode Tripole models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lamitrode Tripole™ 3219STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death270 reports
- Lamitrode Tripole™ 3214STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF61 reports
Recent Lamitrode Tripole adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation
It was reported the patient experienced shocking. As a result the system was explanted to address the issue.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50932099 ↗InjurySep 22, 2026High impedance
It was reported that during the Normal End of Life IPG replacement on (b)(6) 2026 impedances were found on the existing lead. As a result, the lead was also replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50858832 ↗InjurySep 22, 2026Low impedance
It was reported that the patient's lead exhibited low impedances. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849882 ↗InjuryJul 31, 2026High impedance
Additional information received indicates that patient was unable to set the system into MRI mode due to the high impedance.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100411 ↗InjuryJul 28, 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.
Patient problems: Inadequate Pain Relief
MAUDE report 50063823 ↗InjuryJul 27, 2026Therapeutic or Diagnostic Output Failure
It was reported that following recent weight loss, the patient experienced pain and an itching sensation at the IPG site. Additionally, the patient experienced ineffective therapy. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50047706 ↗InjuryJul 27, 2026High impedance
It was reported that the patient experienced ineffective stimulation due to high impedances. As a result, 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 50024496 ↗InjuryJun 23, 2026High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25589431 ↗InjuryJun 11, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 25474485 ↗InjuryJun 5, 2026Fracture
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. LEAD FRACTURE WAS CONFIRMED VIA IMAGING. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS CONFIRMED POST OP.
Patient problems: Inadequate Pain Relief
MAUDE report 25412926 ↗InjuryMay 8, 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 LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25124591 ↗InjuryApr 15, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED PATIENT WAS FEELING TINGLING IN THEIR STOMACH THAT WAS MAKING THEM SICK WHEN THERAPY WAS ON. PROGRAMMING WAS NOT ABLE TO RESOLVE THE ISSUE AND THERAPY WAS TURNED OFF. NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.
Patient problems: Undesired Nerve Stimulation
MAUDE report 24891883 ↗InjuryApr 6, 2026Patient-Device Incompatibility; No Apparent Adverse Event
ADDITIONAL INFORMATION INDICATES THE LEADS WERE REPLACED ELECTIVELY FOR MRI CAPABILITY. THERE IS NO DEVICE MALFUNCTION; THEREFORE, THIS DEVICE IS NO LONGER CONSIDERED REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24791936 ↗InjuryMar 25, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE LEAD SIDE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS TUNNELED DEEPER. DURING THE PROCEDURE IT WAS NOTED THAT THE LEAD WAS COILED UP. EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Implant Pain
MAUDE report 24688694 ↗InjuryMar 24, 2026High impedance
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24683207 ↗
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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