Octrode™ 3086 (UDI 05415067017222)Recalls & reported problems
St. Jude Medical, Inc. · Trial Lead Kit, 60cm Length · Class 2 · Implant
All models of Octrode (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067017222), received between Jun 28, 2018 and Aug 23, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility1
Patient problems
- Blood Loss2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2019Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRIAL PROCEDURE ON (B)(6) 2019 THAT WAS ABANDONED DUE TO PATIENT ANATOMY. THE PATIENT IS STABLE POST OPERATIVELY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8928185 ↗InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 2 OF 2, REFERENCE MFR REPORT: 1627487-2018-06055. IT WAS REPORTED THERE WAS BLEEDING AT THE TRIAL LEAD SITE. AS A RESULT, THE LEADS WERE EXPLANTED (B)(6) 2018.
Patient problems: Blood Loss
MAUDE report 7647460 ↗InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2018-06096. IT WAS REPORTED THERE WAS BLEEDING AT THE TRIAL LEAD SITE. AS A RESULT, THE LEADS WERE EXPLANTED (B)(6) 2018.
Patient problems: Blood Loss
MAUDE report 7646614 ↗
Other STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices
- Octrode™ 3086St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)30 deaths1,538 reports
- Quattrode™ 3166St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)594 reports
- Swift-Lock™ 1192St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
- NA 3386St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)154 reports
- NA 3346St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)117 reports
- Quattrode® 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)81 reports
- Quattrode™ 3163St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)52 reports
- Freedom-8A Receiver Kit Channel A US w/ Receiver FR8A-RCV-A0Stimwave Technologies Incorporated · Stimulator, Spinal-Cord, Implanted (Pain Relief)1 death52 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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