NA DRG (REF MN10550-50)Recalls & reported problems
St. Jude Medical, Inc. · Lead Extension Kit · Class 3 · Implant
Quick summary
This St. Jude Medical dorsal root ganglion stimulator lead extension kit is implanted under the skin to deliver pain-relief signals to nerves. The 38 reports mostly describe leads that would not tighten or advance properly, broke or pulled out of position, or showed high impedance, so stimulation stopped working and patients needed revision surgery to replace or explant the system. 35 injuries and no deaths are reported, along with 3 malfunctions. There are no recalls naming 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
- 37
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 05415067027177), received between Nov 21, 2019 and Apr 27, 2026 — classified as 34 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (9 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
- Mechanical Jam9
- Adverse Event Without Identified Device or Use Problem8
- Therapeutic or Diagnostic Output Failure5
- High impedance4
- Failure to Advance3
- Migration2
- Patient-Device Incompatibility2
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Inadequate Pain Relief12
- Skin Inflammation/ Irritation4
- Unspecified Infection4
- Discomfort2
- Foreign Body In Patient2
- Pain2
- Scar Tissue2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Impedance Problem
IT WAS REPORTED THAT DURING A REVISION PROCEDURE ON (B)(6) 2026 [RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2025-05497], ONE OF THE LEADS PULLED OUT OF POSITION. AS A RESULT, THE LEAD WAS REPLACED. WHILE CONNECTING THE LEADS, AN IMPEDANCE ISSUE WAS FOUND WITH ONE EXTENSION. AS A RESULT, THE LEAD EXTENSION WAS REPLACED. THERAPY WAS RESTORED POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25007377 ↗InjuryNov 8, 2024Fracture; Fracture
IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION WITH DRG SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE SYSTEM WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. DURING THE PROCEDURE IT WAS CONFIRMED THAT THE EXTENSION WAS FRACTURED, IT IS UNKNOWN WHICH EXTENSION FRACTURED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 20638022 ↗InjuryOct 18, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT FOLLOWING A PERMANENT TRIAL PROCEDURE THE PATIENT'S EXTERNAL EXTENSIONS WERE CUT AND LEFT PARTIALLY IMPLANTED, STERI STRIPS WERE APPLIED. ADDITIONAL SURGERY MAY TAKE PLACE TO COMPLETE THE EXTENSION REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 20485350 ↗InjuryOct 18, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT FOLLOWING A PERMANENT TRIAL PROCEDURE THE PATIENT'S EXTERNAL EXTENSIONS WERE CUT AND LEFT PARTIALLY IMPLANTED, STERI STRIPS WERE APPLIED. ADDITIONAL SURGERY MAY TAKE PLACE TO COMPLETE THE EXTENSION REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 20485346 ↗InjuryDec 5, 2023High impedance; High impedance
MANUFACTURER REFERENCE NUMBER: 1627487-2023-05750. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. FURTHER INVESTIGATION REVEALED HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHERE THE LEAD EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18270649 ↗InjuryDec 5, 2023High impedance; High impedance
MANUFACTURER REFERENCE NUMBER: 1627487-2023-05751. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY. FURTHER INVESTIGATION REVEALED HIGH IMPEDANCE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHERE THE LEAD EXTENSIONS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 18270646 ↗InjurySep 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05136, 1627487-2022-05137, 1627487-2022-05139. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 15452105 ↗InjurySep 19, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05136, 1627487-2022-05137, 1627487-2022-05138. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 15452103 ↗InjuryJun 8, 2022High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBERS 1627487-2022-02310, 1627487-2022-02311, 1627487-2022-02312, 1627487-2022-03231. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN ONE LEAD WAS EXPLANTED AND 2 LEADS REMAIN IMPLANTED. ADDITIONALLY, HIGH IMPEDANCES WERE FOUND ON THE EXTENSIONS, THEREFORE THEY WERE EXPLANTED AS WELL. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 14635540 ↗InjuryJun 8, 2022High impedance; High impedance
RELATED MANUFACTURER REPORT NUMBERS 1627487-2022-02310, 1627487-2022-02311, 1627487-2022-02312, 1627487-2022-03232. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY FROM THEIR SYSTEM. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN ONE LEAD WAS EXPLANTED AND 2 LEADS REMAIN IMPLANTED. ADDITIONALLY, HIGH IMPEDANCES WERE FOUND ON THE EXTENSIONS, THEREFORE THEY WERE EXPLANTED AS WELL. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.
Patient problems: Inadequate Pain Relief
MAUDE report 14635367 ↗MalfunctionMay 23, 2022Failure to Advance; Failure to Advance
RELATED MANUFACTURER REFERENCE NUMBER:1627487-2022-02837 AND 1627487-2022-02838. IT WAS REPORTED THAT DURING SURGICAL PROCEDURE FOR LEAD MIGRATION (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02835, 1627487-2022-02834), THE PHYSICIAN WAS UNABLE TO RE-IMPLANT AN EXTENSION. DURING THE ATTEMPT, THE LEAD EXTENSION BROKE WHEN ADVANCING THE LEAD INTO THE EXTENSION. THREE EXTENSIONS WERE OPENED. IT IS UNKNOWN WHICH LEAD EXTENSION IS RELATED TO THE ISSUE. THEREFORE ALL EXTENSIONS ARE BEING REPORTED. THERAPY WAS ESTABLISHED POST-OPERATIVELY, REPORTEDLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468363 ↗MalfunctionMay 23, 2022Failure to Advance; Failure to Advance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02836 AND 1627487-2022-02837. IT WAS REPORTED THAT DURING SURGICAL PROCEDURE FOR LEAD MIGRATION (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02835, 1627487-2022-02834), THE PHYSICIAN WAS UNABLE TO RE-IMPLANT AN EXTENSION. DURING THE ATTEMPT, THE LEAD EXTENSION BROKE WHEN ADVANCING THE LEAD INTO THE EXTENSION. THREE EXTENSIONS WERE OPENED. IT IS UNKNOWN WHICH LEAD EXTENSION IS RELATED TO THE ISSUE. THEREFORE ALL EXTENSIONS ARE BEING REPORTED. THERAPY WAS ESTABLISHED POST-OPERATIVELY, REPORTEDLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468362 ↗MalfunctionMay 23, 2022Failure to Advance; Failure to Advance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02836 AND 1627487-2022-02838. IT WAS REPORTED THAT DURING SURGICAL PROCEDURE FOR LEAD MIGRATION (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02835, 1627487-2022-02834), THE PHYSICIAN WAS UNABLE TO RE-IMPLANT AN EXTENSION. DURING THE ATTEMPT, THE LEAD EXTENSION BROKE WHEN ADVANCING THE LEAD INTO THE EXTENSION. THREE EXTENSIONS WERE OPENED. IT IS UNKNOWN WHICH LEAD EXTENSION IS RELATED TO THE ISSUE. THEREFORE ALL EXTENSIONS ARE BEING REPORTED. THERAPY WAS ESTABLISHED POST-OPERATIVELY, REPORTEDLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14468359 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017884 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017883 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017881 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017880 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017879 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017878 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017875 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01858, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017873 ↗InjuryApr 5, 2022Mechanical Jam; Mechanical Jam
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01859. IT WAS REPORTED DURING AN IPG REVISION (REFERENCE 1627487-2022-01845), THE PHYSICIAN PLANNED TO ADD AN EXTENSION TO THE EXISTING LEAD SO IT COULD BE ROUTED TO THE NEW IPG POCKET. THE PHYSICIAN HAD TROUBLE SECURING THE EXISTING LEAD TO THE NEW EXTENSION. AS A RESULT, THE PHYSICIAN DECIDED NOT TO USE THE EXTENSION, UNBURY THE EXISTING LEAD AND TUNNEL IT TO THE NEW IPG SITE. THE SURGERY WAS EXTENDED 2 HOURS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14017872 ↗InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT DID NOT HAVE AN INFECTION HOWEVER DID HAVE NECROTIC TISSUE.
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12569191 ↗InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT DID NOT HAVE AN INFECTION HOWEVER DID HAVE NECROTIC TISSUE.
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12569173 ↗InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17439, 1627487-2021-17440, 1627487-2021-17442. IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION AT THE EXTENSION SITE. SURGICAL INTERVENTION TOOK PLACE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 12569170 ↗
Other Dorsal root ganglion stimulator for pain relief devices
- SlimTip™ MN10450-50AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief7 deaths8,308 reports
- Proclaim™ DRGSt. Jude Medical, Inc. · Dorsal root ganglion stimulator for pain relief2 recalls8 deaths2,177 reports
- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief1,836 reports
- SlimTip™ MN10450-90AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief8 deaths1,187 reports
- Axium™ MN10200St. Jude Medical, Inc. · Dorsal root ganglion stimulator for pain relief484 reports
- Axium™ MN10450-90ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief443 reports
- SlimTip™ MN10350-50AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief3 deaths373 reports
- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief81 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.