NA 1114Recalls & reported problems
St. Jude Medical, Inc. · Epidural Needle, 14 gauge, 4" (10cm) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734400121), received between Jan 27, 2021 and Jan 27, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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.
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT¿S TRIAL PROCEDURE ON (B)(6) 2021 WAS ABANDONED BECAUSE THE PHYSICIAN EXPERIENCED INSERTION DIFFICULTIES DUE TO THE PATIENT ANATOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11237776 ↗
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.