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St. Jude Medical Infinity™ DBS System (REF 6178)Recalls & reported problems

St. Jude Medical, Inc. · 8CH Directional Lead, 30 cm, 0.5 · Class 3 · Implant

All models of St. Jude Medical Infinity (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067020642), received between Jul 17, 2020 and Jul 17, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (P140009); 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 18, 2026.

Most reported problems

Device problems

  • Fracture2
  • High impedance2
  • Material Fragmentation2

Patient problems

  • Inadequate Pain Relief2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 17, 2020Fracture; High impedance; Fracture; High impedance

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2020-22588. IT WAS REPORTED THAT PATIENT EXPERIENCED A RECENT FALL AND HAD LOSS OF EFFECTIVE STIMULATION. LEAD FRACTURE AND HIGH IMPEDANCE WAS CONFIRMED INTRAOPERATIVELY VIA TRIAL CABLE AND EXTERNAL PULSE GENERATOR. LEFT LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED HOWEVER IT IS UNKNOWN WHICH LEAD IS THE LEFT LEAD THEREFORE BOTH LEADS ARE BEING REPORTED. IMPEDANCES WERE CHECKED POST PROCEDURE AND ALL VALUES WERE WITHIN NORMAL OPTIMAL RANGE AND EFFECTIVE THERAPY WAS RESUMED. PATIENT WAS STABLE.

    Patient problems: Inadequate Pain Relief

    MAUDE report 10292344 ↗
  • InjuryJul 17, 2020Fracture; High impedance; Fracture; High impedance

    RELATED MANUFACTURER REPORT NUMBER 1627487-2020-22932. IT WAS REPORTED THAT PATIENT EXPERIENCED A RECENT FALL AND HAD LOSS OF EFFECTIVE STIMULATION. LEAD FRACTURE AND HIGH IMPEDANCE WAS CONFIRMED INTRAOPERATIVELY VIA TRIAL CABLE AND EXTERNAL PULSE GENERATOR. LEFT LEAD WAS EXPLANTED, AND A NEW LEAD WAS IMPLANTED HOWEVER IT IS UNKNOWN WHICH LEAD IS THE LEFT LEAD THEREFORE BOTH LEADS ARE BEING REPORTED. IMPEDANCES WERE CHECKED POST PROCEDURE AND ALL VALUES WERE WITHIN NORMAL OPTIMAL RANGE AND EFFECTIVE THERAPY WAS RESUMED. PATIENT WAS STABLE.

    Patient problems: Inadequate Pain Relief

    MAUDE report 10292328 ↗
  • InjuryJul 17, 2020Material Fragmentation; Material Fragmentation

    RELATED MANUFACTURER REPORT NUMBER 1627487-2020-22589. IT WAS REPORTED THAT DURING A LEAD EXPLANT PROCEDURE, PHYSICIAN WAS UNABLE TO EXPLANT THE ENTIRE LEAD AND A PARTIAL OF THE LEAD REMAINS SUBCUTANEOUSLY IMPLANTED IN THE BRAIN TISSUE. IT IS UNKNOWN WHICH LEAD HAD THE ISSUE THEREFORE BOTH LEADS ARE BEING REPORTED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. PATIENT WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10292313 ↗
  • InjuryJul 17, 2020Material Fragmentation; Material Fragmentation

    RELATED MANUFACTURER REPORT NUMBER 1627487-2020-22934. IT WAS REPORTED THAT DURING A LEAD EXPLANT PROCEDURE, PHYSICIAN WAS UNABLE TO EXPLANT THE ENTIRE LEAD AND A PARTIAL OF THE LEAD REMAINS SUBCUTANEOUSLY IMPLANTED IN THE BRAIN TISSUE. IT IS UNKNOWN WHICH LEAD HAD THE ISSUE THEREFORE BOTH LEADS ARE BEING REPORTED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. PATIENT WAS STABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10292307 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140009. One submission often covers many models, so check the product and lot details in each record.

  • Z-0459-2026 · Oct 6, 2025 · Open, Classified
    Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
  • Z-2695-2017 · Jun 2, 2017 · Terminated
    Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
  • Z-2693-2017 · Jun 2, 2017 · Terminated
    Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions.
  • Z-2694-2017 · Jun 2, 2017 · Terminated
    Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
  • Z-2696-2017 · Jun 2, 2017 · Terminated
    Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I

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Sources and updates

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