NA 7032Recalls & reported problems
St. Jude Medical, Inc. · DRG External Pulse Generator, 2 Port Header · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067027863), received between Oct 1, 2021 and Mar 23, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE PRODUCT WAS EXPIRED BUT USED IN A PROCEDURE ON (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13869239 ↗InjuryOct 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A DEMO EXTERNAL PULSE GENERATOR HEADER WAS USED FOR A TRIAL PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12562420 ↗
Other Dorsal root ganglion stimulator for pain relief devices
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- 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 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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