Quattrode™ 3159Recalls & reported problems
St. Jude Medical, Inc. · Lead, 3/6mm, 90 cm · Class 3 · Implant
All models of Quattrode (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734406086), received between Jan 11, 2024 and Jan 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (1 report).
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 Failure1
Patient problems
- Inadequate Pain Relief1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 11, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD IS LIABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 18490732 ↗
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 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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