Lamitrode™ 3244Recalls & reported problems
St. Jude Medical, Inc. · 44 Lead Kit, 60cm Length · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Lamitrode 3244 is a lead kit used with an implanted spinal cord stimulator for pain relief. The 56 reports mostly describe leads that stopped delivering effective therapy, with high impedance readings and sometimes broken or disconnected wiring, leading patients to lose pain relief;55 reports involved injuries and no deaths were reported, and some leads had to be removed or replaced in surgery. There are no recalls naming 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
- 56
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 05414734406215), received between Jun 29, 2018 and Nov 7, 2024 — classified as 55 injuries, 1 malfunction.
The most frequently reported specific device problem is “High impedance” (26 reports).
14 other recalls cover devices cleared under the same FDA submission (P010032); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- High impedance26
- Adverse Event Without Identified Device or Use Problem13
- Therapeutic or Diagnostic Output Failure10
- Disconnection4
- Insufficient Device Problem Information3
- Fracture2
- Failure to Advance1
- Failure to Deliver Energy1
Patient problems
- Inadequate Pain Relief47
- Fall3
- No Clinical Signs, Symptoms or Conditions3
- Failure of Implant2
- Insufficient Information2
- No Consequences Or Impact To Patient2
- No Information2
- Erosion1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENTS LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 20636009 ↗InjuryAug 14, 2024High impedance; High impedance
ADDITIONAL INFORMATION WAS OBTAINED, REVEALING THAT THE LEADS WERE REPLACED VIA SURGICAL INTERVENTION ON (B)(6) 2024. IT WAS ALSO CONFIRMED THE PATIENT DID NOT HAVE EFFECTIVE THERAPY PRIOR TO SURGERY. THERAPY WAS RESTORED POST OP.
Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 19980639 ↗InjuryJul 17, 2024Use of Device Problem; Failure to Advance; Use of Device Problem; Failure to Advance
IT WAS REPORTED THAT THE DURING AN IPG REPLACEMENT SURGERY, THE PHYSICIAN NICKED THE INSULATION OF THE LEAD WHEN OPENING THE BATTERY POCKET. THE WIRE WAS SUPERFICIAL ON TOP OF THE BATTERY. THE SURGICAL PROCEDURE WAS ABORTED, AND THE PHYSICIAN CLOSED THE INCISION. THE PATIENT HAD NO THERAPY AT THIS TIME. SURGICAL INTERVENTION MAY TAKE PLACE AT A FUTURE DATE TO ADDRESS THE ISSUE.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 19765078 ↗InjuryFeb 29, 2024High impedance; High impedance
IT WAS REPORTED THAT PATIENT'S LEAD HAD HIGH IMPEDANCES ON ALL CONTACTS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 18809590 ↗InjuryAug 14, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-03818. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 17540173 ↗InjuryAug 14, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-03817. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. AS SUCH, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 17540170 ↗InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02839, 1627487-2023-02954, 1627487-2023-02956. IT WAS REPORTED THAT THE LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 17174972 ↗InjuryMay 31, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING RELIEF FROM THEIR SYSTEM. AS A RESULT, PATIENT HAD SYSTEM EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 17035396 ↗InjuryMay 26, 2023High impedance; High impedance
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHERE IN THE PATIENT'S SCS SYSTEM WAS FULLY EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 17015154 ↗InjuryDec 9, 2022Impedance Problem; Impedance Problem
RELATED MANUFACTURING REPORT NUMBER: 1627487-2022-06750. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO INVALID IMPEDANCES ON THE SCS LEAD AND THE PATIENT LOST EFFECTIVE COVERAGE DUE TO THE L5 DRG LEAD BEING MIGRATED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2022 TO HAVE THEIR BOTH LEADS REPLACED. PATIENT NOW HAS EFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 15954688 ↗InjuryNov 17, 2022Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15811819 ↗InjuryMay 5, 2022High impedance; High impedance
IT WAS REPORTED THE PATIENTS LEAD DISPLAYED HIGH IMPEDANCE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14290346 ↗InjuryMar 2, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01201. IT WAS REPORTED THE PATIENTS SYSTEM DISPLAYED HIGH IMPEDANCES ON ALL CONTACTS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13655961 ↗InjuryMar 2, 2022High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01202. IT WAS REPORTED THE PATIENTS SYSTEM DISPLAYED HIGH IMPEDANCES ON ALL CONTACTS. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13655958 ↗InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES SURGERY TOOK PLACE ON (B)(6) 2022 WHEREIN THE SECOND LEAD WAS EXPLANTED DUE TO THE LEAD ERODING THROUGH THE SKIN. THE SYSTEM WAS REPLACED. THE IPG WAS ELECTIVELY REPLACED.
Patient problems: Erosion
MAUDE report 12840390 ↗InjuryNov 16, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-18398. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PADDLE LEAD AND PERCUTANEOUS LEAD WERE EXPLANTED AND REPLACED WITH A PENTA PADDLE LEAD. DURING THE SURGERY, THE PHYSICIAN ELECTIVELY REPLACED THE IPG AS WELL. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 12825130 ↗InjurySep 12, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIM. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED RESOLVING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 12457993 ↗InjuryJun 1, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 11917365 ↗InjuryFeb 9, 2021High impedance; Therapeutic or Diagnostic Output Failure; High impedance; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Inadequate Pain Relief
MAUDE report 11300618 ↗InjuryFeb 3, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE THERAPY THAT COULD NOT BE RESOLVED BY SYSTEM REPROGRAMMING. IN TURN, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 11276117 ↗InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MFR REPORTS: 1627487-2021-00098 AND 1627487-2021-00100. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S SYSTEM AT AN UNKNOWN DATE AND FOR UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: No Information
MAUDE report 11128439 ↗InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MFR REPORTS: 1627487-2021-00099 AND 1627487-2021-00100. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR'S SYSTEM AT AN UNKNOWN DATE AND FOR UNSPECIFIED REASONS. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.
Patient problems: No Information
MAUDE report 11128433 ↗InjuryDec 6, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
ADDITIONAL INFORMATION WAS RECEIVED THAT SURGERY OCCURRED ON (B)(6) 2020 TO IMPLANT AN ADDITIONAL LEAD TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 10956058 ↗InjuryNov 18, 2020High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 10864322 ↗InjuryNov 16, 2020High impedance; High impedance
IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXHIBITING HIGH IMPEDANCE ON MULTIPLE LEAD CONTACTS. AS A RESULT, THE PATIENT IS NOT RECEIVING STIMULATION THERAPY COVERAGE OF THE PAIN AREA. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 10847417 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P010032. One submission often covers many models, so check the product and lot details in each record.
- Z-0458-2026 · Oct 6, 2025 · Open, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-2510-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2509-2023 · Jul 18, 2023 · Open, ClassifiedProclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
- Z-2505-2023 · Jul 18, 2023 · Open, ClassifiedProclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
- Z-2508-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2506-2023 · Jul 18, 2023 · Open, ClassifiedProclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
- Z-2511-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2507-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2691-2017 · Jun 2, 2017 · TerminatedProclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-2692-2017 · Jun 2, 2017 · TerminatedProclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-1785-2013 · Nov 30, 2012 · TerminatedEon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
- Z-0025-2013 · Sep 4, 2012 · TerminatedThe Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
- Z-1738-2013 · Jul 26, 2012 · TerminatedEon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
- Z-3091-2011 · Jun 2, 2009 · TerminatedSoftware version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
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- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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