Lamitrode TripoleRecalls & reported problems across all models
St. Jude Medical, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 252
- Deaths reported
- 1
- Injuries reported
- 251
- Recalls
- 0
We found 4 models of Lamitrode Tripole by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 252 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and May 19, 2026 — classified as 1 death, 251 injuries.
The most frequently reported specific device problem is “High impedance” (73 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
- High impedance73
- Adverse Event Without Identified Device or Use Problem72
- Therapeutic or Diagnostic Output Failure50
- Migration18
- Fracture13
- Impedance Problem11
- Insufficient Device Problem Information8
- Use of Device Problem5
Patient problems
- Inadequate Pain Relief170
- No Clinical Signs, Symptoms or Conditions29
- Failure of Implant15
- Unspecified Infection11
- No Consequences Or Impact To Patient9
- Pain6
- Undesired Nerve Stimulation6
- Discomfort4
Lamitrode Tripole models
4 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 death201 reports
- Lamitrode Tripole™ 3219STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF22 reports
- Lamitrode Tripole™ 3214STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF20 reports
- Lamitrode Tripole™ 3214STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF9 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.
InjuryMay 19, 2026Use of Device Problem
IT WAS REPORTED THAT DURING A PREVIOUS PROCEDURE WHEREIN THE SYSTEM WAS EXPLANTED, THE LEAD WAS CUT AND A PORTION OF THE LEAD REMAINED IMPLANTED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE REMAINING PORTION OF THE LEAD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25224892 ↗InjuryMay 12, 2026Fracture
IT WAS REPORTED THAT DURING AN IPG REPLACEMENT [RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2026-02604] ON (B)(6) 2026, THE LEAD WAS OBSERVED TO BE VISIBLY FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25153644 ↗InjuryApr 3, 2026Impedance Problem
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER MRI MODE. DIAGNOSTICS REVEALED HIGH AND LOW IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780501 ↗InjuryApr 1, 2026High impedance
IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026, WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757114 ↗InjuryMar 11, 2026High impedance
ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON 01 APRIL 2026 WHEREIN LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570159 ↗InjuryFeb 27, 2026High impedance
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AND NEEDED EXPANDED MRI CAPABILITY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE IPG WAS REPOSITIONED AS WELL AS REPLACED. DURING THE PROCEDURE THE EXISTING LEAD HAD A CONTACT WITH HIGH IMPEDANCES THAT WOULD NOT CLEAR, SO THE LEAD WAS REPLACED AS WELL TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474709 ↗InjuryFeb 19, 2026High impedance
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE AND UNABLE TO ENTER MRI MODE DUE TO HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD AND IPG WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24387359 ↗InjuryJan 15, 2026High impedance
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ENTER THEIR DEVICE INTO MRI MODE DUE TO HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24086970 ↗InjuryJan 9, 2026High impedance
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE. DURING IPG REPLACEMENT THE PATIENTS LEAD HAD A HIGH IMPEDANCE. AS A RESULT, THE LEAD WAS ALSO REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027708 ↗InjuryDec 15, 2025Impedance Problem; Impedance Problem
ADDITIONAL INFORMATION INDICATES THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23813078 ↗InjuryDec 12, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT'S LEAD WAS EXPLANTED AN REPLACED FOR AN UNKNOWN REASON.
Patient problems: Inadequate Pain Relief
MAUDE report 23792707 ↗InjuryNov 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET DISCOMFORT AT BOTH OF THE IPG SITES. THE PATIENT ALSO EXPERIENCED INEFFECTIVE THERAPY WITH THEIR LUMBAR SYSTEM, AND THE CERVICAL LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LUMBAR SYSTEM WAS EXPLANTED, AND THE CERVICAL LEAD AND IPG WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23513963 ↗InjuryNov 7, 2025Migration; Migration
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO LEAD MIGRATION. IT WAS CONFIRMED VIA X-RAY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 23495580 ↗InjuryNov 4, 2025Impedance Problem; Impedance Problem
IT WAS REPORTED THAT PATIENT'S SYSTEM WAS UNABLE TO ENTER MRI MODE DUE TO IMPEDANCES. AS A RESULT, THE LEAD WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23472241 ↗InjuryOct 29, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE ON (B)(6) 2025 [RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2025-05260, 1627487-2025-05261, 1627487-2025-05262], THE LEAD WAS CUT, AND PART OF THE LEAD REMAINS IMPLANTED IN THE PATIENT. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 23410962 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
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- Durata28 models · 19,805 reports
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- Quartet10 models · 11,001 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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