Quattrode® 3161Recalls & reported problems
Advanced Neuromodulation Systems, Inc. · Lead Wide Spaced, 110 cm · Class 2 · Implant
All models of Quattrode (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734401647), received between Apr 4, 2022 and Apr 4, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (4 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.
Most reported problems
Device problems
- Migration4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-01837, 1627487-2022-01838, 1627487-2022-01840, 1627487-2022-01841. IT WAS REPORTED THAT THE LEADS WERE FOUND TO HAVE MIGRATED AND FRACTURED DURING AN INOPERABLE IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-00050) ON (B)(6) 2022. IMAGING CONFIRMED THE FRACTURE AND MIGRATION. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED ALL PERIPHERAL LEADS WITH TWO OCTRODE LEADS DURING THE SAME PROCEDURE. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED. IT IS UNKNOWN WHICH 4 LEADS THE PATIENT HAS IMPLANTED, THEREFORE ALL LEADS ARE BEING REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13996368 ↗InjuryApr 4, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-01837, 1627487-2022-01838, 1627487-2022-01839, 1627487-2022-01841. IT WAS REPORTED THAT THE LEADS WERE FOUND TO HAVE MIGRATED AND FRACTURED DURING AN INOPERABLE IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-00050) ON (B)(6) 2022. IMAGING CONFIRMED THE FRACTURE AND MIGRATION. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED ALL PERIPHERAL LEADS WITH TWO OCTRODE LEADS DURING THE SAME PROCEDURE. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED. IT IS UNKNOWN WHICH 4 LEADS THE PATIENT HAS IMPLANTED, THEREFORE ALL LEADS ARE BEING REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13996364 ↗InjuryApr 4, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-01837, 1627487-2022-01839, 1627487-2022-01840, 1627487-2022-01841. IT WAS REPORTED THAT THE LEADS WERE FOUND TO HAVE MIGRATED AND FRACTURED DURING AN INOPERABLE IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-00050) ON (B)(6) 2022. IMAGING CONFIRMED THE FRACTURE AND MIGRATION. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED ALL PERIPHERAL LEADS WITH TWO OCTRODE LEADS DURING THE SAME PROCEDURE. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED. IT IS UNKNOWN WHICH 4 LEADS THE PATIENT HAS IMPLANTED, THEREFORE ALL LEADS ARE BEING REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13996348 ↗InjuryApr 4, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2022-01838, 1627487-2022-01839, 1627487-2022-01840 AND 1627487-2022-01841. IT WAS REPORTED THAT THE LEADS WERE FOUND TO HAVE MIGRATED AND FRACTURED DURING AN INOPERABLE IPG REPLACEMENT (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-00050) ON 9 MAR 2022. IMAGING CONFIRMED THE FRACTURE AND MIGRATION. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED ALL PERIPHERAL LEADS WITH TWO OCTRODE LEADS DURING THE SAME PROCEDURE. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED. IT IS UNKNOWN WHICH 4 LEADS THE PATIENT HAS IMPLANTED, THEREFORE ALL LEADS ARE BEING REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13996343 ↗
Other STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) devices
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- Quattrode™ 3169St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)401 reports
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- 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
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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