NA 3386Recalls & reported problems
St. Jude Medical, Inc. · Extension, 60cm · Class 2 · Implant
Quick summary
This St. Jude spinal cord stimulator extension connects the implanted stimulator to its leads for pain relief. Many reports describe inadequate pain relief, high electrical resistance, and extensions that migrated, broke or came loose, often leading to surgery. The 156 reports include no deaths and 156 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
- 154
- Deaths reported
- 0
- Injuries reported
- 154
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 05414734402330), received between Jun 15, 2018 and Aug 20, 2026 — classified as 154 injuries.
The most frequently reported specific device problem is “High impedance” (53 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- High impedance53
- Adverse Event Without Identified Device or Use Problem52
- Therapeutic or Diagnostic Output Failure24
- Disconnection7
- Impedance Problem7
- Fracture6
- Use of Device Problem6
- Insufficient Device Problem Information4
Patient problems
- Inadequate Pain Relief93
- Post Operative Wound Infection19
- Unspecified Infection10
- No Clinical Signs, Symptoms or Conditions8
- Discomfort4
- Implant Pain4
- No Consequences Or Impact To Patient4
- Failure of Implant3
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026High impedance
It was reported that following a fall the patient experienced ineffective therapy. Diagnostics revealed high impedances on the lead. Reprogramming has been unable to resolve the issue. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead and both extensions were explanted and replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50356254 ↗InjuryJun 1, 2026Migration
IT WAS REPORTED THAT THE EXTENSIONS MIGRATED AND THE IPG WAS FLIPPING IN THE POCKET. AS A RESULT, THE IPG WAS REPOSITIONED AND THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 25354777 ↗InjuryJun 1, 2026Migration
IT WAS REPORTED THAT THE EXTENSIONS MIGRATED AND THE IPG WAS FLIPPING IN THE POCKET. AS A RESULT, THE IPG WAS REPOSITIONED AND THE EXTENSIONS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 25354756 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE WHEN THE PATIENT MOVED HER HEAD THE EXTENSIONS WERE TUGGING ON THE IPG SITE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE PHYSICIAN LOOSENED UP THE EXTENSIONS AT THE IPG SITE TO ADDRESS THE ISSUE. REPORTEDLY, ISSUE WAS RESOLVED POST OP.
Patient problems: Implant Pain
MAUDE report 24731428 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE WHEN THE PATIENT MOVED HER HEAD THE EXTENSIONS WERE TUGGING ON THE IPG SITE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN THE PHYSICIAN LOOSENED UP THE EXTENSIONS AT THE IPG SITE TO ADDRESS THE ISSUE. REPORTEDLY, ISSUE WAS RESOLVED POST OP.
Patient problems: Implant Pain
MAUDE report 24729135 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTION WAS SUSPECTED. AS A RESULT, SYSTEM WAS REMOVED IN THE SUMMER OF 2025 TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24532146 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT INFECTION WAS SUSPECTED. AS A RESULT, SYSTEM WAS REMOVED IN THE SUMMER OF 2025 TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 24532143 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEADS AND POCKET INCISION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEADS AND EXTENSIONS WERE EXPLANTED.
Patient problems: Post Operative Wound Infection
MAUDE report 24240917 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEADS AND POCKET INCISION. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE LEADS AND EXTENSIONS WERE EXPLANTED.
Patient problems: Post Operative Wound Infection
MAUDE report 24240912 ↗InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD AND LEAD EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 23490452 ↗InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD AND LEAD EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 23490449 ↗InjuryNov 3, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO MIGRATION OF AND HIGH IMPEDANCES ON THE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE LEAD AND LEFT LEAD EXTENSION WERE REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 23458131 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN INFECTION. THE PATIENT'S WHITE BLOOD COUNT WAS HIGH. IN TURN, THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. PATIENT WAS ALSO TREATED FOR THE INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 22807581 ↗InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN INFECTION. THE PATIENT'S WHITE BLOOD COUNT WAS HIGH. IN TURN, THE SCS SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. PATIENT WAS ALSO TREATED FOR THE INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 22807573 ↗InjuryJun 10, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEAD AND EXTENSIONS. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD AND EXTENSIONS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 22181433 ↗InjuryJun 10, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT HAD INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEAD AND EXTENSIONS. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE LEAD AND EXTENSIONS WERE EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 22181432 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS WERE EXPLANTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Post Operative Wound Infection
MAUDE report 22146820 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT THE EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE EXTENSIONS WERE EXPLANTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
Patient problems: Post Operative Wound Infection
MAUDE report 22146819 ↗InjuryMar 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE EXTENSION INCISION SITE (WOUND) HAS NOT CLOSED SINCE IMPLANT. REPORTEDLY, THE WOUND HAS CLOSED AND THERE IS NO MORE PUS.
Patient problems: Impaired Healing; Purulent Discharge; Wound Dehiscence
MAUDE report 21673187 ↗InjuryMar 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE EXTENSION INCISION SITE (WOUND) HAS NOT CLOSED SINCE IMPLANT. REPORTEDLY, THE WOUND HAS CLOSED AND THERE IS NO MORE PUS.
Patient problems: Impaired Healing; Purulent Discharge; Wound Dehiscence
MAUDE report 21673186 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DURING A PROCEDURE TO DISCONNECT EXTENSIONS FOR PERM TRIAL CONVERSION, SIGNIFICANT EVIDENCE OF AN INFECTION WAS PRESENT AND THE ENTIRE SYSTEM WAS EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 21510695 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DURING A PROCEDURE TO DISCONNECT EXTENSIONS FOR PERM TRIAL CONVERSION, SIGNIFICANT EVIDENCE OF AN INFECTION WAS PRESENT AND THE ENTIRE SYSTEM WAS EXPLANTED. PATIENT WAS PRESCRIBED ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Post Operative Wound Infection
MAUDE report 21510691 ↗InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE EXTENSION SITE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE EXTENSIONS WERE EXPLANTED AND REPLACED.
Patient problems: Implant Pain
MAUDE report 21381525 ↗InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE EXTENSION SITE. SURGICAL INTERVENTION WAS UNDERTAKEN, AND THE EXTENSIONS WERE EXPLANTED AND REPLACED.
Patient problems: Implant Pain
MAUDE report 21381524 ↗InjuryNov 21, 2024Disconnection; Disconnection
IT WAS REPORTED PATIENT'S LEAD HAD MIGRATED AND THE EXTENSION WAS DISCONNECTED FROM THE LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 20747504 ↗
Other STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) devices
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- 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 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
- Freedom System Accessories PDBT-915-2KCuronix LLC · Stimulator, Spinal-Cord, Implanted (Pain Relief)34 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.