Proclaim™ 7884Recalls & reported problems
Advanced Neuromodulation Systems, Inc. · DRG Patient Manual and Magnet · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067027313), received between Dec 6, 2018 and Dec 6, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Battery Problem” (1 report).
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.
Most reported problems
Device problems
- Battery Problem1
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 6, 2018Break; Battery Problem
WAS IN MORE PAIN THAN USUALLY AND AFTER A FOLLOW UP WITH A ST. JUDE¿S REPRESENTATIVE, HE TOLD ME THAT ONE LEAD IS BROKEN. SOON AFTER THAT, I NOTICED, THE BATTERY INSIDE MY BODY IS LESS THAN HALFWAY, WHICH I DON¿T THINK IT¿S NORMAL. UNFORTUNATELY, MY PAIN MANAGEMENT DOCTOR HAS ABANDONED ME, NOBODY WANTS TO DO ANYTHING. LOOKING FOR A NEW PAIN MANAGEMENT DOCTOR NOW. AND NEITHER THE REPRESENTATIVES FROM ST JUDE¿S ARE HELPFUL, NO REPORT ABOUT THIS ACCIDENT NOR ANY OTHER KIND OF SHOWING INTEREST ABOUT HELPING ME OUT.
Patient problems: Pain
MAUDE report 8142389 ↗
Other Dorsal root ganglion stimulator for pain relief devices
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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