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Lamitrode™ 3246Recalls & reported problems

St. Jude Medical, Inc. · S-4 Lead Kit, 60cm Length · Class 3 · Implant

All models of Lamitrode (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734406253), received between Feb 27, 2019 and Jul 19, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Therapeutic or Diagnostic Output Failure3
  • Adverse Event Without Identified Device or Use Problem1
  • High impedance1

Patient problems

  • Inadequate Pain Relief5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03766. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03767. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03768. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

    Patient problems: Inadequate Pain Relief

    MAUDE report 15053614 ↗
  • InjuryJul 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03766. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03767. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03769. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

    Patient problems: Inadequate Pain Relief

    MAUDE report 15053598 ↗
  • InjuryMar 17, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

    REFERENCE MANUFACTURER NUMBERS: 1627487-2020-02847, 1627487-2020-02848, 3006705815-2020-01231. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY FROM THEIR SCS SYSTEM. THE PATIENT STATED THAT THEY HAD A MOTOR VEHICLE ACCIDENT ABOUT 5 MONTHS PRIOR, BUT COULD NOT RECALL WHEN THERAPY BECAME INEFFECTIVE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. NOTE: SINCE IT IS NOT KNOWN WHICH DEVICE IS CAUSING THE ISSUE, ALL POSSIBLE DEVICES ARE BEING REPORTED ON.

    Patient problems: Inadequate Pain Relief

    MAUDE report 9844738 ↗
  • InjuryFeb 27, 2019High impedance; High impedance

    DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2019-02518, 1627487-2019-02521 (DEVICE MIGRATION). IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEAD AND EXTENSION DURING INTRA-OPERATIVE TESTING AFTER AN IPG REPLACEMENT. THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE HIGH IMPEDANCE. IT WAS REPORTED THAT EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

    Patient problems: Inadequate Pain Relief

    MAUDE report 8376438 ↗
  • InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REFERENCE MFR. REPORT# 1627487-2019-02518, 1627487-2019-02519 (FOR HIGH IMPEDANCES). IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEAD AND EXTENSION DURING INTRA-OPERATIVE TESTING AFTER AN IPG REPLACEMENT ON (B)(6) 2019. IT WAS ALSO NOTED THE OTHER LEAD HAD MIGRATED FROM ORIGINAL LOCATION. THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED TO ADDRESS THE HIGH IMPEDANCE. THE OTHER LEAD WAS REVISED. IT WAS REPORTED THAT EFFECTIVE THERAPY WAS RESTORED POST-OPERATIVELY.

    Patient problems: Inadequate Pain Relief

    MAUDE report 8376414 ↗

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, Classified
    Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
  • Z-2509-2023 · Jul 18, 2023 · Open, Classified
    Proclaim 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-2511-2023 · Jul 18, 2023 · Open, Classified
    Infinity 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-2510-2023 · Jul 18, 2023 · Open, Classified
    Infinity 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-2506-2023 · Jul 18, 2023 · Open, Classified
    Proclaim" 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-2507-2023 · Jul 18, 2023 · Open, Classified
    Proclaim 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-2508-2023 · Jul 18, 2023 · Open, Classified
    Proclaim 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-2505-2023 · Jul 18, 2023 · Open, Classified
    Proclaim 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-2692-2017 · Jun 2, 2017 · Terminated
    Proclaim 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-2691-2017 · Jun 2, 2017 · Terminated
    Proclaim 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-1785-2013 · Nov 30, 2012 · Terminated
    Eon 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 · Terminated
    The 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 · Terminated
    Eon - 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 · Terminated
    Software 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

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Sources and updates

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