Quattrode™ 3163Recalls & reported problems
St. Jude Medical, Inc. · Lead Wide Spaced, 30 cm · Class 2 · Implant
All models of Quattrode (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Quattrode 3163 is a wide-spaced spinal cord stimulator lead implanted under the skin to deliver pain relief to the lower back or legs. Most of the 52 reports describe leads that stopped giving effective pain relief, often with high electrical impedance, and several that shifted position or broke, so reprogramming did not help and patients had surgery to remove or replace the leads. The reports describe 52 injuries and no deaths.
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
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 05414734406093), received between Jul 12, 2018 and Jun 10, 2026 — classified as 52 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (15 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.
Reports received per month
Most reported problems
Device problems
- Therapeutic or Diagnostic Output Failure15
- Adverse Event Without Identified Device or Use Problem12
- High impedance10
- Migration7
- Fracture6
- Use of Device Problem3
- Impedance Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Inadequate Pain Relief44
- Failure of Implant2
- Fall2
- Implant Pain2
- No Clinical Signs, Symptoms or Conditions2
- Undesired Nerve Stimulation2
- Foreign Body In Patient1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026High impedance
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION. ONE LEAD HAD SEVERAL HIGH IMPEDANCES. REPROGRAMMING COULD NOT RESTORE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE LEADS WERE REMOVED AND REPLACED WITH A SURGICAL LEAD TO ADDRESS THE ISSUE. IT CANNOT BE DETERMINED WHICH LEAD CONTRIBUTED TO THE EVENT.
Patient problems: Inadequate Pain Relief
MAUDE report 25461181 ↗InjuryApr 2, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT IS UNKNOWN WHICH LEAD WAS AT FAULT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED WITH A PADDLE LEAD.
Patient problems: Inadequate Pain Relief
MAUDE report 24769369 ↗InjuryFeb 19, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24392940 ↗InjuryOct 15, 2025Migration; Migration
ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23306439 ↗InjuryOct 15, 2025Migration; Migration
IT WAS REPORTED PATIENT'S LEADS HAVE MIGRATED AFTER A FALL. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23300254 ↗InjuryFeb 4, 2025High impedance; High impedance
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHERE THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21307272 ↗InjuryNov 26, 2024Inappropriate/Inadequate Shock/Stimulation; Therapeutic or Diagnostic Output Failure; Inappropriate/Inadequate Shock/Stimulation; Therapeutic or Diagnostic Output Failure
ADDITIONAL INFORMATION RECEIVED INDICATED, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024, WHERE IN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief; Undesired Nerve Stimulation
MAUDE report 20787681 ↗InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED SLIGHT COMPRESSION OF THE SPINAL CORD WITH THE LEADS. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 DURING WHICH BOTH SCS AND DRG SYSTEMS WERE EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19448333 ↗InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED SLIGHT COMPRESSION OF THE SPINAL CORD WITH THE LEADS. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 DURING WHICH BOTH SCS AND DRG SYSTEMS WERE EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19448327 ↗InjuryMar 26, 2024High impedance; High impedance
ADDITIONAL INFORMATION INDICATES THAT PATIENT WAS ALSO EXPERIENCING PAIN AT IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN IPG AND LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 18977955 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2024-07634 IT WAS REPORTED THAT THE WOUND AT THE PATIENT¿S IPG SITE WAS NOT HEALING PROPERLY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 THE POCKET WAS OPENED AND THE WOUND WAS FLUSHED. DURING THE PROCEDURE, IT WAS NOTED THAT A LEAD WITH AN ANCHOR ATTACHED WAS SITTING BEHIND SOME TISSUE NEAR THE POCKET SITE. AS A RESULT, THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Impaired Healing
MAUDE report 18970325 ↗InjuryJan 8, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2024-00231, 3006705815-2024-00232. IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THEIR SCS SYSTEM AND DISCOMFORT AT THE IPG SITE. AS A RESULT, THE ENTIRE SYSTEM WAS REPLACED AND THE IPG SITE WAS REPOSITIONED.
Patient problems: Inadequate Pain Relief
MAUDE report 18469747 ↗InjuryMay 26, 2023High impedance; High impedance
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2023 WHERE IN THE PATIENT'S SCS SYSTEM WAS FULLY EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 17015150 ↗InjuryMay 14, 2023Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT DURING IPG REPLACEMENT SURGERY ON (B)(6) 2023, THE PATIENTS LEAD WAS FOUND TO HAVE A LEAD THAT WAS CUT AND LEFT IMPLANTED FROM A PROCEDURE ON AN UNKNOWN DATE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO REMOVE THE LEAD.
Patient problems: Foreign Body In Patient
MAUDE report 16928318 ↗InjuryApr 13, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
ADDITIONAL INFORMATION INDICATES THAT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 16736574 ↗InjuryMar 16, 2023Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01143. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY AND THAT THE IPG HAD BECOME INOPERABLE. THE 3163 LEAD NEVER PROVIDED EFFECTIVE RELIEF. THE IPG WAS LAST RECHARGED APPROXIMATELY A YEAR AGO. AS SUCH, THE IPG WOULD NO LONGER COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS EXPLANTED AND THE IPG WAS EXPLANTED THEN REPLACED. EFFECTIVE THERAPY WAS ACHIEVED.
Patient problems: Inadequate Pain Relief
MAUDE report 16561886 ↗InjuryDec 9, 2022Migration; Migration
RELATED MANUFACTURING REPORT NUMBER: 1627487-2022-06749. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO INVALID IMPEDANCES ON THE SCS LEAD AND THE PATIENT LOST EFFECTIVE COVERAGE DUE TO THE L5 DRG LEAD BEING MIGRATED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2022 TO HAVE THEIR BOTH LEADS REPLACED. PATIENT NOW HAS EFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 15953961 ↗InjuryDec 9, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-18495, 3006705815-2022-18496. IT WAS REPORTED THE PATIENT'S LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE EXISTING LEADS WERE EXPLANTED AND REPLACED. DURING THE PROCEDURE, A LEAD HAD SHEARED AND WAS NOT IMPLANTED. A NEW LEAD WAS IMPLANTED. THERAPY WAS RESTORED POST-SURGERY.
Patient problems: Inadequate Pain Relief
MAUDE report 15948999 ↗InjuryNov 2, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05696. IT WAS REPORTED THAT THE PATIENT'S S1 LEAD WAS EXPLANTED AND REPLACED DUE TO INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 15718890 ↗InjurySep 9, 2022Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16418, 1627487-2022-04900. IT WAS REPORTED THAT DURING IPG EXPLANT PROCEDURE ON (B)(6) 2022 (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16418), THE LEADS WERE CUT AND LEFT IN SITU. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15397075 ↗InjurySep 9, 2022Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16418, 1627487-2022-04901. IT WAS REPORTED THAT DURING IPG EXPLANT PROCEDURE ON (B)(6) 2022 (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16418), THE LEADS WERE CUT AND LEFT IN SITU. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15397054 ↗InjuryJul 2, 2022Migration; Migration
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY CONFIRMED THE SQ LEAD MIGRATED FROM L5. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 14897421 ↗InjuryApr 4, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-01846, 1627487-2022-01847, 1627487-2022-01848, AND 1627487-2022-01850. IT WAS REPORTED THE PATIENT HAD THEIR PNS SYSTEM EXPLANTED WITH NO COMPLICATIONS DUE TO INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 14006849 ↗InjuryApr 4, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-01846, 1627487-2022-01847, 1627487-2022-01849, AND 1627487-2022-01850. IT WAS REPORTED THE PATIENT HAD THEIR PNS SYSTEM EXPLANTED WITH NO COMPLICATIONS DUE TO INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 14006840 ↗InjuryApr 4, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-01846, 1627487-2022-01848, 1627487-2022-01849, AND 1627487-2022-01850. IT WAS REPORTED THE PATIENT HAD THEIR PNS SYSTEM EXPLANTED WITH NO COMPLICATIONS DUE TO INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 14006828 ↗
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- Quattrode® 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Freedom-8A Receiver Kit Channel A US w/ Receiver FR8A-RCV-A0Stimwave Technologies Incorporated · Stimulator, Spinal-Cord, Implanted (Pain Relief)1 death52 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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