Quattrode™ 3169Recalls & reported problems
St. Jude Medical, Inc. · Lead Wide Spaced, 90 cm · Class 2 · Implant
Quick summary
This St. Jude Medical Quattrode lead is an implanted nerve stimulation lead used for pain relief. Its 405 adverse event reports often describe leads shifting out of place, high electrical resistance and failed stimulation output, and many describe inadequate pain relief. The reports include no deaths and 405 injuries. No recalls name this device.
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
- 401
- Deaths reported
- 0
- Injuries reported
- 401
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 401 adverse event reports that list this exact device (DI 05414734406116), received between Jun 14, 2018 and Jul 27, 2026 — classified as 401 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (71 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
- Adverse Event Without Identified Device or Use Problem216
- Therapeutic or Diagnostic Output Failure71
- High impedance50
- Migration47
- Fracture15
- Impedance Problem12
- Inappropriate/Inadequate Shock/Stimulation8
- Failure to Deliver Energy2
Patient problems
- Inadequate Pain Relief232
- Discomfort32
- Erosion25
- Unspecified Infection23
- Pain21
- Post Operative Wound Infection18
- Implant Pain16
- Undesired Nerve Stimulation9
Recent adverse event reports
The 25 most recent of 401 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's incision site where the anchors are was not healing properly. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue.4432.
Patient problems: Wound Dehiscence
MAUDE report 50015910 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's incision site where the anchors are was not healing properly. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue.
Patient problems: Wound Dehiscence
MAUDE report 50015909 ↗InjuryApr 22, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE CERVICAL LEAD. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24956900 ↗InjuryApr 22, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS REVEALED HIGH IMPEDANCES ON THE CERVICAL LEAD. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24956887 ↗InjuryNov 4, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY DUE TO LEAD MIGRATION. THE ISSUE WAS CONFIRMED VIA X-RAYS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD WAS REPOSITIONED. EFFECTIVE THERAPY RESTORED. NOTE: IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23465903 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND BURNING SENSATIONS AT THE LOCATION OF THE LEADS. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.
Patient problems: Burning Sensation; Implant Pain
MAUDE report 23442441 ↗InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND BURNING SENSATIONS AT THE LOCATION OF THE LEADS. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.
Patient problems: Burning Sensation; Implant Pain
MAUDE report 23442434 ↗InjuryAug 5, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN (B)(6) 2022 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE STIMULATION.
Patient problems: Movement Disorder
MAUDE report 22720005 ↗InjuryJul 21, 2025High impedance; High impedance
IT WAS REPORTED THE PATIENT'S LEFT OCCIPITAL LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 22558310 ↗InjuryApr 30, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED THE INEFFECTIVE STIMULATION.
Patient problems: Inadequate Pain Relief
MAUDE report 21937892 ↗InjuryAug 5, 2024High impedance; High impedance
IT WAS REPORTED THAT FOLLOWING MULTIPLE FALLS PATIENTS LEADS WERE AUTOREDUCING, PATIENTS LEADS HAVE HIGH IMPEDANCES. PATIENTS IPG IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 19913615 ↗InjuryAug 5, 2024High impedance; High impedance
IT WAS REPORTED THAT FOLLOWING MULTIPLE FALLS PATIENTS LEADS WERE AUTO REDUCING, PATIENTS LEADS HAVE HIGH IMPEDANCES. PATIENTS IPG IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 19913614 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON 3JUNE2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, IT WAS REPORTED THE LEFT SUPRA ORBITAL LEAD WAS UNCOMFORTABLE AND THE TIP OF THE LEAD WAS VISIBLE ON THE PATIENT'S FOREHEAD. CONSEQUENTLY, THE LEFT SUPRA ORBITAL LEAD WAS REPOSITIONED, DURING THE 3JUNE2024 SURGICAL PROCEDURE, TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST-OP. IT IS UNKNOWN WHICH SUPRAORBITAL LEAD WAS LIABLE.
Patient problems: Erosion
MAUDE report 19618946 ↗InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY AND HAD PAIN AT THE IPG AND LEAD SITES. REPROGRAMMING WAS ATTEMPTED. PHYSICIAN ALSO PRESCRIBED MEDICATIONS FOR PAIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19590388 ↗InjuryJun 21, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY AND HAD PAIN AT THE IPG AND LEAD SITES. REPROGRAMMING WAS ATTEMPTED. PHYSICIAN ALSO PRESCRIBED MEDICATIONS FOR PAIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 19590382 ↗InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY AND HAD PAIN AT THE IPG AND LEAD SITES. REPROGRAMMING WAS ATTEMPTED. PHYSICIAN ALSO PRESCRIBED MEDICATIONS FOR PAIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19590381 ↗InjuryMay 24, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LIABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 19391628 ↗InjuryApr 3, 2024High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED PATIENT WAS EXPERIENCING UNCOMFORTABLE AND INEFFECTIVE THERAPY. TROUBLE SHOOTING WAS UNABLE TO SOLVE THE ISSUE. AS SUCH SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief; Undesired Nerve Stimulation
MAUDE report 19036733 ↗InjuryMar 1, 2024High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-07257. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE IPG SITE, AND PATIENTS PERC LEAD HAD HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN PATIENTS SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18817192 ↗InjuryFeb 3, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2024-00620. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE LEFT SUPRA-ORBITAL AND LEFT OCCIPITAL LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE LEFT SUPRA-ORBITAL LEAD AND THE LEFT OCCIPITAL LEAD WERE REPOSITIONED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST-OP. IT IS UNKNOWN WHICH SUPRA-ORBITAL LEAD, AND WHICH OCCIPITAL LEAD ARE LIABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 18637402 ↗InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED SUSPECTED INFECTION AND ALLERGY AT THE LEFT SUPRAORBITAL LEAD SITE. PATIENT'S BODY WAS REJECTING THE LEFT SUPRAORBITAL LEAD AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. THE PATIENT WAS ADMINISTERED BOTH ORAL AND IV ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Hypersensitivity/Allergic reaction; Post Operative Wound Infection
MAUDE report 18527541 ↗InjuryJan 11, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00200, 1627487-2024-00201 AND 1627487-2024-00202. IT WAS REPORTED PATIENT'S SCS SYSTEM DID NOT PROVIDE EFFECTIVE THERAPY AND WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Inadequate Pain Relief
MAUDE report 18494686 ↗InjuryJan 9, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00199, 1627487-2024-00201, 1627487-2024-00202. IT WAS REPORTED PATIENT'S SCS SYSTEM DID NOT PROVIDE EFFECTIVE THERAPY AND WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Inadequate Pain Relief
MAUDE report 18480119 ↗InjuryJan 9, 2024Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-05862 RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00170 RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00172 RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00173 RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00174 IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, ALL OF PATIENTS LEADS HAD SHIFTED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 ,WHEREIN BOTH OF PATIENTS SYSTEMS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18474877 ↗InjuryDec 8, 2023Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00167. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00170. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00172. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00173. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00174. ADDITIONAL INFORMATION INDICATES ALL OF THE PATIENTS LEADS HAD SHIFTED.
Patient problems: Inadequate Pain Relief
MAUDE report 18297276 ↗
Other STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) devices
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- Nalu Medical, Inc. 71019-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall225 reports
- StimQ Receiver Stimulator Kit Channel A US w/Receiver STQ4-RCV-A0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)3 deaths270 reports
- Nalu Medical, Inc. 71020-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)213 reports
- StimQ Spare Lead Kit Channel B US w/Receiver STQ4-SPR-B0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)126 reports
- Nalu Medical, Inc. 71005-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall73 reports
- Nalu Medical, Inc. 71020Nalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)101 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.