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PMPClass 3

Dorsal Root Ganglion Stimulator For Pain Relief

FDA adverse event reports and recall history for dorsal root ganglion stimulator for pain relief (product code PMP), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
19,566
Deaths
32
Injuries
19,289
Malfunctions
243

Reports per year

16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 20162026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2024-07-16Open, ClassifiedVendor change control

    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

    The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

  • 2018-03-23TerminatedSoftware change control

    Proclaim DRG Implantable Pulse Generator, Model Number 3664

    The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.

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