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Axium™ MN10600-02Recalls & reported problems

St. Jude Medical, Inc. · Patient Programmer Kit · Class 3

All models of Axium (2)

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 05415067025586), received between Dec 23, 2020 and Apr 21, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (4 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, 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

  • Migration4
  • 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.

  • InjuryApr 21, 2022Migration; Migration

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-02283. IT WAS REPORTED THAT PATIENT'S LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 IN WHICH THE LEADS WERE EXPLANTED AND REPLACED.

    Patient problems: Inadequate Pain Relief

    MAUDE report 14175655 ↗
  • InjuryApr 21, 2022Migration; Migration

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-02284. IT WAS REPORTED THAT PATIENT'S LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 IN WHICH THE LEADS WERE EXPLANTED AND REPLACED.

    Patient problems: Inadequate Pain Relief

    MAUDE report 14175558 ↗
  • InjuryFeb 11, 2021High impedance; High impedance

    RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-01165. IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS WERE SHOWING HIGH IMPEDANCE ON MULTIPLE CONTACTS. IT WAS REPORTED THAT THE SECOND LEAD IS PROVIDING THERAPY. SURGERY MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS RELATED TO THE ISSUE. THEREFORE, ALL THE SUSPECTED DEVICES ARE BEING REPORTED.

    Patient problems: Inadequate Pain Relief

    MAUDE report 11317669 ↗
  • InjuryDec 23, 2020Migration; Migration

    MANUFACTURER REFERENCE NUMBER: 1627487-2020-49106. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION, AND IT WAS CONFIRMED WITH X-RAY. DURING PROCEDURE ON (B)(6) 2020 THE OTHER LEAD MIGRATED. PHYSICIAN EXPLANTED AND REPLACED BOTH LEADS, AND THERAPY WAS RESTORED.

    Patient problems: Inadequate Pain Relief

    MAUDE report 11068755 ↗
  • InjuryDec 23, 2020Migration; Migration

    MANUFACTURER REFERENCE NUMBER: 1627487-2020-49105. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION, AND IT WAS CONFIRMED WITH X-RAY. DURING PROCEDURE ON (B)(6) 2020 THE OTHER LEAD MIGRATED. PHYSICIAN EXPLANTED AND REPLACED BOTH LEADS, AND THERAPY WAS RESTORED.

    Patient problems: Inadequate Pain Relief

    MAUDE report 11068658 ↗

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Sources and updates

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