QuattrodeRecalls & reported problems across all models
St. Jude Medical, Inc. · 17 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,757
- Deaths reported
- 0
- Injuries reported
- 1,757
- Recalls
- 0
We found 17 models of Quattrode by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,757 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2018 and Sep 28, 2026 — classified as 1,757 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (415 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quattrode problems
Device problems
- Adverse Event Without Identified Device or Use Problem710
- Therapeutic or Diagnostic Output Failure415
- High impedance255
- Migration207
- Fracture88
- Inappropriate/Inadequate Shock/Stimulation47
- Impedance Problem46
- Insufficient Device Problem Information41
Patient problems
- Inadequate Pain Relief1,099
- Implant Pain105
- Erosion91
- Discomfort72
- Unspecified Infection65
- No Clinical Signs, Symptoms or Conditions63
- Post Operative Wound Infection58
- Pain57
Quattrode models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quattrode™ 3166STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)594 reports
- Quattrode™ 3166STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)429 reports
- Quattrode™ 3169STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)401 reports
- Quattrode® 3163STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Quattrode™ 3146STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF57 reports
- Quattrode™ 3163STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)52 reports
- Quattrode™ 3149STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF50 reports
- Quattrode™ 3156STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF46 reports
- Quattrode™ 3146STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF16 reports
- Quattrode™ 3066STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)8 reports
- Quattrode™ 3149STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF8 reports
- Quattrode™ 3153STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF5 reports
- Quattrode™ 3156STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF4 reports
- Quattrode™ 3143STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Quattrode™ 3156STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 reports
- Quattrode™ 3159STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
- Quattrode™ 3149STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
Recent Quattrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Migration
It was reported that the patient experienced ineffective therapy and headaches. X-ray imaging revealed migration of the Left Occipital lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue.
Patient problems: Headache; Inadequate Pain Relief
MAUDE report 50917646 ↗InjurySep 24, 2026Migration
It was reported that the patient's lead migrated. X-ray imaging revealed migration of the left supraorbital lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue.
Patient problems: Insufficient Information
MAUDE report 50888635 ↗InjurySep 22, 2026Migration
It was reported that the patient's right Supra-orbital lead had migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue. X-ray imaging revealed the right occipital lead was accidentally moved during the procedure. As a result, the patient returned to surgery on (b)(6) 2026 wherein the right occipital lead was repositioned to address the issue. Effective therapy was restored post operatively. It is unknown which leads were the right Supra-orbital and right occipital lead.
Patient problems: Inadequate Pain Relief
MAUDE report 50860383 ↗InjurySep 22, 2026Use of Device Problem
It was reported that the patient's right Supra-orbital lead had migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue. X-ray imaging revealed the right occipital lead was accidentally moved during the procedure. As a result, the patient returned to surgery on (b)(6) 2026 wherein the right occipital lead was repositioned to address the issue. Effective therapy was restored post operatively. It is unknown which leads were the right Supra-orbital and right occipital lead.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860382 ↗InjurySep 22, 2026Migration
It was reported that the patient experienced ineffective therapy. X-ray imaging revealed migration of the lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was repositioned to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50849947 ↗InjurySep 21, 2026Migration
It was reported that following recent weight loss, the patient experienced pain at the IPG site. Additionally, the right Occipital lead migrated and bent and another lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was repositioned, the right Occipital lead was explanted and replaced, and the other lead was repositioned to address the issue. It is unknown which lead migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846752 ↗InjurySep 21, 2026Material Twisted/Bent
It was reported that following recent weight loss, the patient experienced pain at the IPG site. Additionally, the right Occipital lead migrated and bent and another lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was repositioned, the right Occipital lead was explanted and replaced, and the other lead was repositioned to address the issue. It is unknown which lead migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846748 ↗InjurySep 21, 2026Migration
It was reported that following recent weight loss, the patient experienced pain at the IPG site. Additionally, the right Occipital lead migrated and bent and another lead migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was repositioned, the right Occipital lead was explanted and replaced, and the other lead was repositioned to address the issue. It is unknown which lead migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846746 ↗InjurySep 16, 2026High impedance
It was reported that the patient experienced ineffective therapy. Troubleshooting revealed high impedances on the leads. 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 50793875 ↗InjurySep 16, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50793873 ↗InjurySep 16, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50793861 ↗InjurySep 16, 2026High impedance
It was reported that the patient's leads exhibited high impedances. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790613 ↗InjurySep 16, 2026Migration
It was reported that the patient experienced ineffective therapy, the leads were uncomfortable and visible. X-ray imaging revealed migration of two leads. As a result, surgical intervention was undertaken wherein the system was explanted to address the issue.
Patient problems: Implant Pain; Inadequate Pain Relief
MAUDE report 50789583 ↗InjurySep 16, 2026Migration
It was reported that the patient experienced ineffective therapy, the leads were uncomfortable and visible. X-ray imaging revealed migration of two leads. As a result, surgical intervention was undertaken wherein the system was explanted to address the issue.
Patient problems: Implant Pain; Inadequate Pain Relief
MAUDE report 50789581 ↗InjuryAug 31, 2026High impedance
It was reported that the patient's leads exhibited high impedances. As a result, surgical intervention may be undertaken to address the issue. It is unknown which lead exhibited the high impedances
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532528 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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