NeuRx Diaphragm Pacing System 20-0035Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00852184003007), received between Jul 19, 2016 and Jul 12, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Contamination” (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. May 31, 2022Class IIITerminated

   Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

   Z-1393-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED A CARDIAC EVENT THAT REQUIRED RESUSCITATION.

  Patient problems: Arrhythmia

  MAUDE report 12155402 ↗
• InjuryMar 4, 2019Positioning Problem

  THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION DURING PROGRAMMING OF HIS SECOND EXTERNAL PULSE GENERATOR (EPG) ON THE DAY FOLLOWING SURGICAL IMPLANTATION OF THE NEURX DIAPHRAGM PACING SYSTEM (DPS). THE PATIENT IS A (B)(6) OBESE MALE WITH A PARALYZED LEFT DIAPHRAGM DUE TO PHRENIC NERVE DAMAGE FOLLOWING A THORACIC AORTIC ANEURYSM ON (B)(6) 2018. ON (B)(6) 2019 TWO PERMALOC ELECTRODES WERE IMPLANTED INTO THE LEFT SIDE DIAPHRAGM VIA THORACOTOMY ALONG WITH LEFT PHRENIC NERVE RECONSTRUCTION. STIMULATION WAS TESTED AT MAXIMUM SETTINGS WHILE THE PATIENT WAS IN THE SUPINE POSITION WITHOUT INCIDENT. INITIAL PROGRAMMING OF THE EPG WAS PERFORMED WITHOUT DISCOMFORT, ALTHOUGH THE PATIENT WAS ON HIGH POST OP PAIN MEDICATION. ON (B)(6) 2019 SETTINGS WERE BEING FINE-TUNED AS THE PATIENT WAS THEN ON LESS PAIN MEDICATION. ONE EPG WAS LEFT AT THE SETTINGS ESTABLISHED THE PREVIOUS DAY AS THEY WERE TOLERATED WITHOUT DISCOMFORT. TO ESTABLISH SETTINGS FOR THE SECOND EPG THE SETTINGS WERE INCREASED TO DETERMINE THE POINT WHERE THE PATIENT WOULD START TO FEEL SENSATION FROM STIMULATION. AT THIS POINT THE PATIENT SUDDENLY BECAME UNRESPONSIVE AND HAD NO PULSE. HOSPITAL MEDICAL STAFF STARTED CPR, THE PATIENT

  Patient problems: Ventricular Fibrillation

  MAUDE report 8388270 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE MEDICAL FACILITY: PT ADMITTED DUE TO RIGHT HEMOTHORAX, LEFT SIDED CHEST PAIN EMESIS, ACUTE BLOOD LOSS ANEMIA AND HYPOTENSION. PT PRESENTED TO ER AFTER HAVING CHEST PAIN WORSE WITH INSPIRATION WHICH WAS SUDDEN ONSET WHILE IN THE SHOWER ON (B)(6) 2017 AT 9:15 AM. UPON ADMITTANCE PT STILL COMPLAINED OF CHEST PAIN AND HAD SEVERAL EPISODES OF EMESIS. CT PERFORMED IN ER SHOWING LARGE COMPRESSIVE LEFT COMPLEX FLUID COLLECTION. PHYSICIANS DRAINED THE FLUID VIA PIGTAIL AND SENT FLUID FOR ANALYSIS WHICH SHOWED NO GROWTH AFTER 5 DAYS.

  Patient problems: Anemia; Chest Pain; Hemothorax; Low Blood Pressure/ Hypotension

  MAUDE report 6682904 ↗
• InjuryDec 2, 2016Contamination

  THE PATIENT WAS EXPERIENCING RECURRING INFECTIONS AT THE PERCUTANEOUS EXIT SITE OF THE LEAD WIRES OF THE DIAPHRAGM PACING SYSTEM. THE CAREGIVER FOR THE PATIENT WAS INSTRUCTED ON PROPER EXIT SITE CARE BUT THE INFECTION DID NOT CLEAR WITH THIS INTERVENTION. A COURSE OF ANTIBIOTIC TREATMENT CLEARED THE INFECTION BUT INFECTION RECURRED WHEN THE ANTIBIOTIC TREATMENT ENDED. THE ATTENDING PHYSICIAN DECIDED TO EXPLANT THE ELECTRODES AND DEBRIDE THE AREA, WHICH TOOK PLACE ON (B)(6) 2016. RECOVERY WAS NORMAL FOLLOWING THE EXPLANT AND THE PATIENT MAY BE REIMPLANTED AT A LATER DATE.

  Patient problems: Unspecified Infection

  MAUDE report 6142010 ↗
• InjuryJul 19, 2016Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS A (B)(6) YEAR OLD FEMALE WHO SUFFERED A C5-C7 SPINAL CORD INJURY FOLLOWING SURGICAL RESECTION OF A CYST ON HER SPINE LEAVING HER WITH QUADRIPLEGIA. SHE WAS SUCCESSFULLY IMPLANTED WITH THE DIAPHRAGM PACING SYSTEM (B)(6) 2013. IN 2016 THE PATIENT'S HEALTH BEGAN TO DECLINE AND SHE WAS HOSPITALIZED EARLIER IN THE YEAR (PRECISE DATE(S) UNKNOWN) FOR TREATMENT OF SMA SYNDROME DUE TO RECENT SIGNIFICANT WEIGHT LOSS. NO CARDIAC ARRHYTHMIAS WERE NOTED DURING THAT STAY AND THE PATIENT WAS DISCHARGED. THE PATIENT FURTHER DECLINED AND WAS READMITTED TO THE SAME HOSPITAL IN (B)(6) 2016 WITH BILATERAL PULMONARY EMBOLI AND HYDRONEPHROSIS, WHICH WERE TREATED. IT WAS NOTED THAT WHEN THE DIAPHRAGM PACER WAS TURNED ON AND SHE WENT FROM POSITIVE CHEST PRESSURE VENTILATION TO NEGATIVE CHEST PRESSURE VENTILATION SHE CONSISTENTLY DEVELOPED VENTRICULAR COUPLETS AND AT ONE POINT EXPERIENCED VENTRICULAR TACHYCARDIA. AT THAT TIME ALL DIAPHRAGM PACING WAS DISCONTINUED AND VENTILATION WAS MAINTAINED BY MECHANICAL VENTILATION ALONE THROUGH HER TRACHEOSTOMY. AN ECHOCARDIOGRAM PERFORMED AT THE TIME SHOWED INCREASED PULMONARY PRESSURES CONSISTENT WITH HER PULMONARY EMBOLI AND NO PERICARDIAL FLUID WAS

  Patient problems: Arrhythmia; Death

  MAUDE report 5804354 ↗