LamitrodeRecalls & reported problems across all models
St. Jude Medical, Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 219
- Deaths reported
- 0
- Injuries reported
- 218
- Recalls
- 0
We found 12 models of Lamitrode by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 219 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2018 and Apr 13, 2026 — classified as 218 injuries, 1 malfunction.
The most frequently reported specific device problem is “High impedance” (79 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 impedance79
- Therapeutic or Diagnostic Output Failure43
- Adverse Event Without Identified Device or Use Problem36
- Migration16
- Fracture15
- Insufficient Device Problem Information12
- Impedance Problem11
- Disconnection6
Patient problems
- Inadequate Pain Relief170
- No Clinical Signs, Symptoms or Conditions14
- Failure of Implant13
- Insufficient Information7
- No Consequences Or Impact To Patient7
- Undesired Nerve Stimulation5
- Unspecified Infection5
- Fall4
Lamitrode models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lamitrode™ 3244STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF56 reports
- Lamitrode™ 3286STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF35 reports
- Lamitrode™ 3288STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF35 reports
- Lamitrode™ 3245STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF31 reports
- Lamitrode™ 3286STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF27 reports
- Lamitrode™ 3245STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF14 reports
- Lamitrode™ 3240STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF10 reports
- Lamitrode™ 3246STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF5 reports
- Lamitrode™ 3245STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Lamitrode™ 3268STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Lamitrode™ 3268STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- Lamitrode™ 3283STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
Recent Lamitrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 13, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 24866014 ↗InjuryMar 18, 2026High impedance
ADDITIONAL INFORMATION INDICATES THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24627521 ↗InjuryMar 8, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN LEADS WERE REPLACED TO ADDRESS THE ISSUE. IT CANNOT BE DETERMINED WHICH LEAD CONTRIBUTED TO THE EVENT.
Patient problems: Inadequate Pain Relief
MAUDE report 24541778 ↗InjuryMar 6, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE SYSTEM WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 24536472 ↗InjuryFeb 19, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24392958 ↗InjuryJan 22, 2026High impedance
IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Inadequate Pain Relief
MAUDE report 24144285 ↗InjuryJan 2, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT WAS ALSO REPORTED THAT ONE OF THE PATIENT'S LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. FLUOROSCOPY IMAGING REVEALED MIGRATION OF THE REMAINING LEAD. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23952704 ↗InjuryDec 19, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT'S LEAD EXHIBITED HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851614 ↗InjuryDec 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT'S LEAD WAS FRACTURED. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23821810 ↗InjuryNov 19, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE ON THE LEAD. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23597824 ↗InjuryJul 22, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE THORACIC LEAD. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE LEAD. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAS HIGH IMPEDANCE.
Patient problems: Inadequate Pain Relief
MAUDE report 22563876 ↗InjuryMay 13, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22012767 ↗InjuryMar 24, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM AND DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21681633 ↗InjuryMar 7, 2025High impedance; High impedance
IT WAS REPORTED THAT IMPEDANCE CHECK REVEALED HIGH IMPEDANCE ON THE LEAD. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE. PATIENT HAS EFFECTIVE THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548473 ↗InjuryFeb 20, 2025High impedance; Impedance Problem; High impedance; Impedance Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. DIAGNOSTIC TESTING REVEALED MULTIPLE IMPEDANCE ISSUES ON BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION MAY OCCURRED ON A LATER DATE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21425650 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
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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