NeuRx DPS™ External Pulse Generator 23-0021Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00852184003212), received between May 24, 2021 and Jul 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Jul 11, 2022Class ITerminated

   Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly.

   Z-1561-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT EXPERIENCED SEVERE PAIN ON THE LEFT SIDE OF THEIR DIAPHRAGM UPON INITIALIZATION OF STIMULATION WITH AN EXTERNAL PULSE GENERATOR. STIMULATION WAS REPEATED WITH A SECOND EXTERNAL PULSE GENERATOR AND THERE WAS NO DISCOMFORT.

  Patient problems: Abdominal Pain

  MAUDE report 14939989 ↗
• MalfunctionMay 24, 2021Electrical Overstress; Electrical Overstress

  THE PATIENT'S OLDER EXTERNAL PULSE GENERATOR (EPG, APPROX 8 YEARS OLD) WAS BEING EXCHANGED FOR A NEW EPG. THE STIMULATION SETTINGS WERE RETRIEVED FROM THE OLD EPG AND WERE PROGRAMMED INTO THE NEW EPG. WHEN STIMULATION WAS STARTED WITH THE NEW EPG THE PATIENT EXPERIENCED INTENSE PAIN AND STIMULATION WAS DISCONTINUED. THE SETTINGS WERE VERIFIED BUT THE PATIENT AGAIN EXPERIENCED INTENSE PAIN WHEN STIMULATION WAS INITIATED A SECOND TIME. THE OLD EPG WAS LEFT WITH THE PATIENT AND THE NEW DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11872593 ↗