Octrode™ 3086 (UDI 05414734401555)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
Quick summary
This St. Jude Medical Octrode trial lead kit is a lead used to test spinal cord stimulation before a full implant. The 1,529 reports most often mention spinal fluid leaks, pain, wound infections, headaches, and bleeding or hematoma. Some reports describe a lead being severed during a trial, leaving pieces in the patient. The reports list 30 deaths and 1,495 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,538
- Deaths reported
- 30
- Injuries reported
- 1,504
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,538 adverse event reports that list this exact device (DI 05414734401555), received between Jun 13, 2018 and Sep 29, 2026 — classified as 30 deaths, 1,504 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (185 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,228
- Patient-Device Incompatibility185
- Migration30
- Use of Device Problem21
- High impedance15
- Material Fragmentation15
- No Apparent Adverse Event9
- Fracture8
Patient problems
- Cerebrospinal Fluid Leakage285
- No Consequences Or Impact To Patient273
- Pain161
- Post Operative Wound Infection129
- Headache116
- Hematoma84
- Inadequate Pain Relief74
- No Clinical Signs, Symptoms or Conditions73
Recent adverse event reports
The 25 most recent of 1,538 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported following an SCS trial procedure, patient reported decreased feeling in both feet. MRI confirmed fluid on the spinal cord and patient was admitted to the hospital. Patient is regaining some feeling back in her feet and doing gait training to regain independence with walking.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 50937772 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported following an SCS trial procedure, patient reported decreased feeling in both feet. MRI confirmed fluid on the spinal cord and patient was admitted to the hospital. Patient is regaining some feeling back in her feet and doing gait training to regain independence with walking.
Patient problems: Paraplegia
MAUDE report 50937769 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported following a trial procedure on (b)(6) 2026 the patient experienced significant pain resulting in a fall and the patient needing stitches. Surgical intervention took place wherein the trial system was explanted to address the issue.NOTE: It is unknown which lead is related to this issue.
Patient problems: Fall; Implant Pain
MAUDE report 50936454 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Intraoperative Pain
MAUDE report 50925414 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following trail lead placement the patient developed significant pain in the left leg and foot. As a result, the leads were removed. It cannot be determined which lead contributed to the event.
Patient problems: Implant Pain
MAUDE report 50858453 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at the leads site. As a result, surgical intervention was undertaken on (b)(6) 2026 where in the entire system was explanted to address the issue. The patient was hospitalized and administered antibiotics to address the issue.
Patient problems: Post Operative Wound Infection
MAUDE report 50849912 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at the leads site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue. The patient was hospitalized and administered antibiotics to address the issue.
Patient problems: Post Operative Wound Infection
MAUDE report 50849907 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced a Hematoma and the inability to walk and was hospitalized. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the leads were explanted to address the issue. It is unknown which lead the allegation is against.
Patient problems: Hematoma; Muscle Weakness/Atrophy
MAUDE report 50789437 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during an SCS trial procedure on(b)(6) 2026, a Cerebrospinal Fluid (CSF) leak occurred while the physician was placing a lead. As a result, the leads were removed to address the issue. It is unknown which lead is related to this issue.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 50762794 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following the trial lead placement the patient reported a bad headache and nausea. The physician advised the patient to rest and drink a caffeinated beverage which resolved the patient¿s symptoms. Trial continues without further issue.
Patient problems: Headache; Nausea
MAUDE report 50406478 ↗InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during a trial procedure on (b)(6) 2026 the patient experienced pain and the procedure could not be continued. As a result, the trial was abandoned. Following discontinuation of the trial, the pain resolved.
Patient problems: Pain
MAUDE report 50383201 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during a trial system explant, a Cerebrospinal Fluid (CSF) leak occurred while the physician was removing the lead. As a result, a blood patch was performed to address the issue.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 50078058 ↗InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED DIFFICULTY BREATHING FOLLOWING THE TRIAL PROCEDURE DUE TO OTHER UNDERLYING HEALTH ISSUES. AS A RESULT, THE PROCEDURE WAS ABORTED AND THE LEAD WAS REMOVED TO ADDRESS THE ISSUE. PATIENT WAS ESCORTED TO THE HOSPITAL.
Patient problems: Decreased Respiratory Rate
MAUDE report 25586078 ↗InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER SCS LEAD TRIAL PROCEDURE, PATIENT EXPERIENCED HEMATOMA. AS A RESULT, SURGICAL INTERVENTION, WAS UNDERTAKEN WHEREIN THE LEADS WERE EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED HEMATOMA.
Patient problems: Hematoma
MAUDE report 25556049 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED EPIDURAL HEMATOMA AND WAS HOSPITALIZED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE TRAIL LEADS WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED EPIDURAL HEMATOMA.
Patient problems: Hematoma
MAUDE report 25179490 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A CEREBROSPINAL FLUID (CSF) OCCURRED DURING A TRIAL PROCEDURE ON (B)(6) 2026 AND THE SURGERY WAS ABANDONED. PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. NOTE: IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 25145352 ↗InjuryMay 8, 2026Use of Device Problem
IT WAS REPORTED THAT THE PATIENT'S TRIAL LEADS WERE SEVERED AND PORTIONS OF THE LEAD REMAIN IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 25120321 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMATOMA. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEAD WAS EXPLANTED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD CAUSED THE HEMATOMA.
Patient problems: Hematoma
MAUDE report 25048641 ↗InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A TRIAL IMPLANT PROCEDURE ON (B)(6) 2026 THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAKAGE. AS SUCH, A BLOOD PATCH WAS PERFORMED TO ADDRESS THE ISSUE, AND DUE TO PATIENT ANATOMY, THE PROCEDURE WAS ABANDONED. REPORTEDLY, PATIENT HAD NOT NOTED ANY SIGNIFICANT SYMPTOMS OR SIDE EFFECTS FROM THE CSF LEAKAGE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24957272 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK. AS A RESULT, A BLOOD PATCH WAS PERFORMED TO ADDRESS THE ISSUE.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24824004 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STAPH INFECTION AT THE LEAD SITE FOLLOWING THE TRIAL LEADS REMOVAL. THE INFECTION HAS RESOLVED AND THE PATIENT IS DOING FINE.
Patient problems: Unspecified Infection
MAUDE report 24681350 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STAPH INFECTION AT THE LEAD SITE FOLLOWING THE TRIAL LEADS REMOVAL. THE INFECTION HAS RESOLVED AND THE PATIENT IS DOING FINE.
Patient problems: Unspecified Infection
MAUDE report 24681344 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST TRAIL PROCEDURE AND PROGRAMMING THE PATIENT WAS TRANSPORTED TO THE ER DUE TO CHEST PAINS. THE PATIENT WAS ADMITTED DUE TO ABNORMAL CARDIAC MARKER AND UNDERWENT CARDIAC STENT THE FOLLOWING DAY. THE PATIENT WAS DISCHARGED ON (B)(6) 2026 AND WAS CLEARED BY CARDIOLOGIST TO RESUME STIMULATION TRAIL. IT IS UNKNOWN IF TRAIL PROCEDURE CONTRIBUTED TO THIS ADVERSE EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.
Patient problems: Unspecified Heart Problem
MAUDE report 24650521 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A CSF LEAK DURING THEIR TRIAL PROCEDURE AND THE PROCEDURE WAS ABORTED. THE PATIENT HAD A BLOOD PATCH COMPLETED AND NO OTHER SYMPTOMS WERE REPORTED.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24650386 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DURING A TRIAL LEAD IMPLANT PROCEDURE ON (B)(6) 2026, THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK. A BLOOD PATCH WAS COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 24613022 ↗
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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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