QuattrodeRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 132
- Deaths reported
- 0
- Injuries reported
- 132
- Recalls
- 0
We found 5 models of Quattrode by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 132 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Jun 10, 2026 — classified as 132 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (36 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
- Therapeutic or Diagnostic Output Failure36
- High impedance27
- Migration22
- Adverse Event Without Identified Device or Use Problem19
- Insufficient Device Problem Information16
- Fracture6
- Inappropriate/Inadequate Shock/Stimulation3
- Impedance Problem2
Patient problems
- Inadequate Pain Relief92
- No Clinical Signs, Symptoms or Conditions11
- Undesired Nerve Stimulation6
- Failure of Implant5
- No Consequences Or Impact To Patient5
- Implant Pain4
- Insufficient Information4
- No Known Impact Or Consequence To Patient4
Quattrode models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quattrode® 3146STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF101 reports
- Quattrode® 3159STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF13 reports
- Quattrode® 3153STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF8 reports
- Quattrode® 3143STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 reports
- Quattrode® 3161STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)4 reports
Recent Quattrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Migration
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS REPOSITIONED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD MIGRATED.
Patient problems: Inadequate Pain Relief
MAUDE report 25460703 ↗InjuryMay 29, 2026Migration
IT WAS REPORTED THAT DURING A IPG REPLACEMENT PROCEDURE ON (B)(6) 2026, ONE OF THE QUATTRODE LEADS WAS VISUALLY CONFIRMED TO BE FRACTURED AND ANOTHER QUATTRODE LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY IMAGING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25331662 ↗InjuryMay 29, 2026Fracture
IT WAS REPORTED THAT DURING A IPG REPLACEMENT PROCEDURE ON (B)(6) 2026, ONE OF THE QUATTRODE LEADS WAS VISUALLY CONFIRMED TO BE FRACTURED AND ANOTHER QUATTRODE LEAD HAD MIGRATED WHICH WAS CONFIRMED THROUGH X-RAY IMAGING. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25331609 ↗InjuryApr 23, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPROGRAMMING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD ATTRIBUTED TO THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24975216 ↗InjuryApr 15, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. 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
MAUDE report 24884292 ↗InjuryMar 30, 2026Migration
IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS MIGRATED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD WAS REPOSITIONED TO RESOLVE THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24737507 ↗InjuryMar 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24546417 ↗InjuryMar 9, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. STIMULATION WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 24546413 ↗InjuryJan 26, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD TWO OF THEIR SYSTEM LEADS EXPLANTED IN 2022 FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24185381 ↗InjuryJan 26, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD TWO OF THEIR SYSTEM LEADS EXPLANTED IN 2022 FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24185372 ↗InjuryDec 11, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23782672 ↗InjuryDec 11, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON THE LEADS. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23782641 ↗InjuryNov 3, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD WAS AT FAULT.
Patient problems: Inadequate Pain Relief
MAUDE report 23455732 ↗InjurySep 19, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT WAS ALSO REPORTED THAT PATIENT HAS AN ACTIVE LIFESTYLE AND USES A RIDING LAWN MOWER. DIAGNOSTICS REVEALED THAT BOTH OF PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS, EXTENSION, AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23094096 ↗InjurySep 19, 2025High impedance; High impedance
IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. IT WAS ALSO REPORTED THAT PATIENT HAS AN ACTIVE LIFESTYLE AND USES A RIDING LAWN MOWER. DIAGNOSTICS REVEALED THAT BOTH OF PATIENT'S LEADS EXHIBITED HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEADS, EXTENSION, AND IPG WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23094091 ↗
Other Advanced Neuromodulation Systems, Inc. products
All Advanced Neuromodulation Systems, Inc. devices →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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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