Quattrode® 3163Recalls & reported problems
St. Jude Medical, Inc. · Lead Wide Spaced, 30 cm · Class 2 · Implant
Quick summary
This St. Jude Medical Quattrode spinal cord stimulator lead is an implanted pain-relief device. Reports mostly describe ineffective therapy and lead migration, sometimes requiring surgery. There are 81 reports: no deaths and 81 injuries; no recalls name this device. Reports fell to 0 in the last 12 months from 3.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 05414734401654), received between Oct 18, 2018 and Sep 5, 2025 — classified as 81 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (40 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
- Therapeutic or Diagnostic Output Failure40
- Migration11
- Adverse Event Without Identified Device or Use Problem9
- Insufficient Device Problem Information8
- High impedance6
- Inappropriate/Inadequate Shock/Stimulation3
- Fracture2
- Impedance Problem2
Patient problems
- Inadequate Pain Relief64
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient4
- Insufficient Information2
- Scar Tissue2
- Undesired Nerve Stimulation2
- Device Overstimulation of Tissue1
- Erosion1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22984570 ↗InjuryMay 13, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON BOTH LEADS. SURGICAL INTERVENTION MAY TAKE PLACE IN THE FUTURE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22012764 ↗InjuryJan 2, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21061753 ↗InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LEAD WAS SHOWING THROUGH THE SKIN ABOUT 1MM AND CAUSING PAIN/DISCOMFORT. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED. THERAPY WAS RESTORED POST-OP.
Patient problems: Erosion; Implant Pain
MAUDE report 20297421 ↗InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION DUE TO LEAD MIGRATION. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS MIGRATED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation
MAUDE report 18659516 ↗InjuryNov 2, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHERE THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THE IPG WAS ELECTIVELY REPLACED. EFFECTIVE STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 18062320 ↗InjurySep 6, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-04229. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THEIR PERIPHERAL SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LIABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 17689326 ↗InjuryJun 30, 2023Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03103, 1627487-2023-03104. IT WAS REPORTED THE PATIENT EXPERIENCED LEAD MIGRATION AND AN INOPERABLE IPG DUE TO NOT RECHARGING THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG AND LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 17239806 ↗InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02839, 1627487-2023-02954, 1627487-2023-02955. IT WAS REPORTED THAT THE LEAD WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 17174961 ↗InjuryMay 31, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02570. IT WAS REPORTED THAT BOTH OF THE PATIENT'S LEADS HAD HIGH IMPEDANCES AS A RESULT THE PATIENT LOST EFFECTIVE THERAPY. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 17035657 ↗InjuryMay 23, 2023Therapeutic or Diagnostic Output Failure; Migration; Therapeutic or Diagnostic Output Failure; Migration
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02838. ADDITIONAL INFORMATION INDICATES THAT THE LEADS HAD MIGRATED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 16985770 ↗InjuryApr 5, 2023Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01518. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MINOR FALL AND AS A RESULT THE PATIENT'S LEADS HAD MIGRATED AND WAS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE AT A FUTURE DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 16686280 ↗InjuryJan 11, 2023High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-00125. IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE IPG. POST OPERATIVELY IT WAS REPORTED ONE OF THE PATIENT'S LEADS HAD ALL HIGH IMPEDANCES. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY. PATIENT IS TO FOLLOW-UP WITH PHYSICIAN AS THE NEXT COURSE OF ACTION.
Patient problems: Inadequate Pain Relief
MAUDE report 16141806 ↗InjuryJan 8, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A LEAD REVISION PROCEDURE A PART OF THE LEAD HAD FRACTURED AND A FRAGMENT OF THE LEAD WITH THE DISTAL CONTACTS REMAINS IMPLANTED IN THE SOFT TISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16119442 ↗InjuryJul 1, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-03697. IT WAS REPORTED THE PATIENT'S LEADS MIGRATED. THE ISSUE WAS CONFIRMED VIA X-RAY. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14883303 ↗InjuryJun 15, 2022High impedance; Battery Problem: High Impedance; High impedance; Battery Problem: High Impedance
RELATED MANUFACTURER NUMBER: 1627487-2022-03409. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCE. SURGERY MAY TAKE PLACE LATER. IT IS UNKNOWN WHICH LEAD PRESENTS THE ISSUE, THEREFORE BOTH LEADS ARE BEING REPORTED.
Patient problems: Inadequate Pain Relief
MAUDE report 14709053 ↗InjuryMay 15, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-02777, 1627487-2022-02779, AND 1627487-2022-02780. IT WAS REPORTED THAT THE PATIENT HAD A FALL IN MARCH 2022 AND LOST EFFECTIVE THERAPY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE LEADS WERE EXPLANTED AND REPLACED, RESOLVING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14404070 ↗InjuryMay 5, 2022Impedance Problem; Impedance Problem
RELATED MANUFACTURER NUMBER: 1627487-2022-02325, AND 1627487-2022-02327. IT WAS REPORTED THE PATIENT EXPERIENCED AUTOREDUCING AND LATER LOST THERAPY AS THE IPG REACHED END OF SERVICE (EOS). IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14292915 ↗InjuryMar 23, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-01541, 3006705815-2022-01441. IT WAS REPORTED ONE OF THE PATIENT'S LEADS HAD MIGRATED AND THE IPG HAS FLIPPED IN THE POCKET. SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13858872 ↗InjuryMar 4, 2022Fracture; Fracture
RELATED MANUFACTURER REFERENCE NUMBER : 1627487-2022-01230. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED THAT BOTH THE LEADS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE IN THE BOTH THE LEADS WERE EXPLANTED AND REPLACED ADDRESSING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13666225 ↗InjuryMar 4, 2022Fracture; Fracture
RELATED MANUFACTURER REFERENCE NUMBER : 1627487-2022-01183. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED THAT BOTH THE LEADS WERE FRACTURED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE IN THE BOTH THE LEADS WERE EXPLANTED AND REPLACED ADDRESSING THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 13666221 ↗InjuryJan 31, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00558, 1627487-2022-00559, 1627487-2022-00560. IT WAS REPORTED THE PATIENTS PERIPHERAL SYSTEM WAS NOT PROVIDING EFFECTIVE THERAPY, THEREFORE THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 13399995 ↗InjuryJan 31, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00558, 1627487-2022-00559, 1627487-2022-00561. IT WAS REPORTED THE PATIENTS PERIPHERAL SYSTEM WAS NOT PROVIDING EFFECTIVE THERAPY, THEREFORE THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 13399950 ↗InjuryJan 31, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00559, 1627487-2022-00560, 1627487-2022-00561. IT WAS REPORTED THE PATIENTS PERIPHERAL SYSTEM WAS NOT PROVIDING EFFECTIVE THERAPY, THEREFORE THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 13399894 ↗InjuryJan 31, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00558, 1627487-2022-00560, 1627487-2022-00561. IT WAS REPORTED THE PATIENTS PERIPHERAL SYSTEM WAS NOT PROVIDING EFFECTIVE THERAPY, THEREFORE THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 13399871 ↗
Other STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices
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- Quattrode™ 3166St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)594 reports
- 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)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
- Freedom System Accessories PDBT-915-2KCuronix LLC · Stimulator, Spinal-Cord, Implanted (Pain Relief)34 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.