SJM™ 3013Recalls & reported problems
St. Jude Medical, Inc. · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734405355), received between Oct 4, 2021 and May 23, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method3
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT DURING A PROCEDURE AN EXPIRED MLTC CABLE WAS USED. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080339 ↗MalfunctionMar 29, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT AN EXPIRED MLTC CABLE WAS USED DURING THE PATIENT'S IMPLANT PROCEDURE. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13935543 ↗MalfunctionMar 29, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT AN EXPIRED MLTC CABLE WAS USED DURING THE PATIENT'S IMPLANT PROCEDURE. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13935338 ↗InjuryOct 4, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT A DEMO TRIAL CABLE WAS USED IN A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12570523 ↗
Other STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices
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- Swift-Lock™ 1192St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
- NA 3386St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)154 reports
- NA 3346St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)117 reports
- Quattrode® 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Quattrode™ 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)52 reports
- Freedom-8A Receiver Kit Channel A US w/ Receiver FR8A-RCV-A0Stimwave Technologies Incorporated · Stimulator, Spinal-Cord, Implanted (Pain Relief)1 death52 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.