NA 3346Recalls & reported problems
St. Jude Medical, Inc. · Extension, Dual 4 Channel 60cm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical spinal cord stimulator extension has 117 adverse event reports, with 117 injuries and no deaths. Many describe inadequate pain relief, and some describe stimulation that stopped working, high electrical resistance or fractures in the extension. 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
- 117
- Deaths reported
- 0
- Injuries reported
- 117
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 05414734402309), received between Jun 27, 2018 and Aug 3, 2026 — classified as 117 injuries.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (32 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 Problem50
- Therapeutic or Diagnostic Output Failure32
- High impedance20
- Fracture12
- Insufficient Device Problem Information4
- Use of Device Problem4
- Migration2
- Therapy Delivered to Incorrect Body Area2
Patient problems
- Inadequate Pain Relief59
- Unspecified Infection12
- Implant Pain10
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions5
- Discomfort4
- Pain4
- Undesired Nerve Stimulation4
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following weight loss, the patient experienced skin erosion at the lead and extension sites. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Erosion
MAUDE report 50119206 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following weight loss, the patient experienced skin erosion at the lead and extension sites. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Erosion
MAUDE report 50119188 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 22479617 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE EXTENSION SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 22479616 ↗InjuryOct 7, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING IPG REPLACEMENT PROCEDURE, THE EXTENSION WAS FOUND TO BE FRACTURED. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THIS ISSUE. THERAPY WAS RESTORED.
Patient problems: Failure of Implant
MAUDE report 20392823 ↗InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY AND HAD PAIN AT THE IPG AND LEAD SITES. REPROGRAMMING WAS ATTEMPTED. PHYSICIAN ALSO PRESCRIBED MEDICATIONS FOR PAIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19590390 ↗InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT EXPERIENCED INEFFECTIVE THERAPY AND HAD PAIN AT THE IPG AND LEAD SITES. REPROGRAMMING WAS ATTEMPTED. PHYSICIAN ALSO PRESCRIBED MEDICATIONS FOR PAIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHERE THE ENTIRE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 19590386 ↗InjuryNov 2, 2023Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-07095. RELATED MANUFACTURER REFERENCE NUMBER:1627487-2023-05189. IT WAS REPORTED THAT PATIENT HAD LOST WEIGHT AND IPG HAD ERODED THROUGH THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN IPG WAS EXPLANTED, AND EXTENSIONS WERE CUT BELOW THE HEADER TO ADDRESS THE ISSUE. PATIENT WAS ADMINISTERED ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 18061488 ↗InjuryNov 2, 2023Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT PATIENT HAD LOST WEIGHT AND IPG HAD ERODED THROUGH THE SKIN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN IPG WAS EXPLANTED, AND EXTENSIONS WERE CUT BELOW THE HEADER TO ADDRESS THE ISSUE. PATIENT WAS ADMINISTERED ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Foreign Body In Patient
MAUDE report 18061388 ↗InjuryJul 11, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-03276. IT WAS REPORTED THAT THE PATIENT HAD BOTH EXTENSIONS EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCES.
Patient problems: Inadequate Pain Relief
MAUDE report 17303026 ↗InjuryJul 11, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-03275. IT WAS REPORTED THAT THE PATIENT HAD BOTH EXTENSIONS EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCES.
Patient problems: Inadequate Pain Relief
MAUDE report 17303022 ↗InjuryJul 6, 2023High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ISSUES. SURGICAL INTERVENTION TOOK PLACE WHERE THE PATIENTS LEAD EXTENSIONS WERE EXPLANTED AND REPLACED. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-03143.
Patient problems: Inadequate Pain Relief
MAUDE report 17267868 ↗InjuryJul 6, 2023High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ISSUES. SURGICAL INTERVENTION TOOK PLACE WHERE THE PATIENTS LEAD EXTENSIONS WERE EXPLANTED AND REPLACED. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4).
Patient problems: Inadequate Pain Relief
MAUDE report 17267864 ↗InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02357. IT WAS REPORTED THAT THE PATIENT HAD A INFECTION AT THE EXTENSION POCKET SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSIONS WERE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16949953 ↗InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 1627487-2023-02358. IT WAS REPORTED THAT THE PATIENT HAD A INFECTION AT THE EXTENSION POCKET SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE EXTENSIONS WERE EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 16949940 ↗InjuryMar 21, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01234, 1627487-2023-01235. IT WAS REPORTED THE PATIENT DID NOT RECHARGE THEIR IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE, AND STIMULATION WAS LOST AS IPG COULD NO LONGER COMMUNICATE WITH EXTERNAL DEVICES (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-01234). SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. DURING PROCEDURE, BOTH EXTENSIONS HAD HIGH IMPEDANCES AND WERE EXPLANTED AND REPLACED AS WELL. THERAPY WAS RESTORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16587995 ↗InjuryMar 21, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-01234, 1627487-2023-01236. IT WAS REPORTED THE PATIENT DID NOT RECHARGE THEIR IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE, AND STIMULATION WAS LOST AS IPG COULD NO LONGER COMMUNICATE WITH EXTERNAL DEVICES (RELATED MANUFACTURER REFERENCE NUMBER 1627487-2023-01234). SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. DURING PROCEDURE, BOTH EXTENSIONS HAD HIGH IMPEDANCES AND WERE EXPLANTED AND REPLACED AS WELL. THERAPY WAS RESTORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16587993 ↗InjuryDec 9, 2022Fracture; High impedance; Fracture; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06693. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. X-RAYS INDICATED THERE WAS A FRACTURE IN THE SPLITTER. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15949030 ↗InjuryDec 9, 2022Fracture; High impedance; Fracture; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06694. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. X-RAYS INDICATED THERE WAS A FRACTURE IN THE SPLITTER. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15949028 ↗InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16553, 1627487-2022-04828, 1627487-2022-04829, 1627487-2022-04830, 1627487-2022-04831, 1627487-2022-04833. IT WAS REPORTED THAT PATIENT EXPERIENCED DISCOMFORT AT THE LEAD AND EXTENSION SITES. THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG COULD NO LONGER COMMUNICATE WITH THE CHARGER. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.
Patient problems: Implant Pain
MAUDE report 15407695 ↗InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2022-16553, 1627487-2022-04828, 1627487-2022-04829, 1627487-2022-04830, 1627487-2022-04831, 1627487-2022-04832. IT WAS REPORTED THAT PATIENT EXPERIENCED DISCOMFORT AT THE LEAD AND EXTENSION SITES. THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG COULD NO LONGER COMMUNICATE WITH THE CHARGER. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.
Patient problems: Implant Pain
MAUDE report 15407629 ↗InjuryAug 23, 2022High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IT WAS FOUND THAT THE EXTENSION HAD HIGH IMPEDANCES. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 15277227 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 3006705815-2022-15958, 1627487-2022-04280, 1627487-2022-04281, 1627487-2022-04392, 1627487-2022-04393, 1627487-2022-04394, 3006705815-2022-16070, 1627487-2022-04396, 1627487-2022-04397, 1627487-2022-04398, 1627487-2022-04399. IT WAS REPORTED AN INFECTION WAS PRESENT AT THE IPG SITE. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE PATIENT'S CERVICAL SCS AND DBS SYSTEM WERE LATER EXPLANTED DUE TO INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 15217925 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 3006705815-2022-15958, 1627487-2022-04280, 1627487-2022-04392, 1627487-2022-04393, 1627487-2022-04394, 1627487-2022-04395, 3006705815-2022-16070, 1627487-2022-04396, 1627487-2022-04397, 1627487-2022-04398, 1627487-2022-04399. IT WAS REPORTED AN INFECTION WAS PRESENT AT THE IPG SITE. PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. THE PATIENT'S CERVICAL SCS AND DBS SYSTEM WERE LATER EXPLANTED DUE TO INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 15217883 ↗InjuryApr 11, 2022Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01922. IT WAS REPORTED THE PATIENT'S EXTENSIONS BECAME SUPERFICIAL CAUSING PAIN TO THE PATIENT. AS A RESULT, SURGICAL INTERVENTION OCCURRED ON (B)(6) 2022 WHEREIN THE EXTENSIONS WERE SUTURED DEEPER INTO THE POCKET TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 14069569 ↗
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- 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
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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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