Barostim NEO2 2104Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 00859144004623), received between Jan 5, 2023 and Sep 30, 2026 — classified as 22 deaths, 158 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 180 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Unintended Movement

  Patient problems: Pocket Erosion

  MAUDE report 50949201 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50902921 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50900425 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  A Barostim system was implanted on (b)(6) 2026. Approximately one day after implant while still in inpatient care, a hematoma was observed at the IPG site and drainage was required. Approximately three days after the patient was discharged it was observed that the neck incision had not scabbed and continued to have drainage and oozing. The patient was admitted to the hospital for approximately five to six days and treated with oral and IV antibiotics. Culture were taken on (b)(6) 2026 and results were negative. There were no known factors that caused or contributed to the event. It was confirmed the patient withheld anticoagulants prior to the procedure per standard of care and restarted after discharge. Per the physician the event was considered known potential complications associated with the surgical procedure. As of (b)(6) 2026 the patient was doing well and the hematoma and neck incision complications had fully resolved.

  Patient problems: Fluid Discharge; Hematoma

  MAUDE report 50616198 ↗
• InjurySep 1, 2026Use of Device Problem

  Patient problems: Post Operative Wound Infection; Skin Inflammation/ Irritation; Swelling/ Edema; Twiddlers Syndrome; Wound Dehiscence

  MAUDE report 50553610 ↗
• InjuryAug 28, 2026Use of Device Problem

  A Barostim system was implanted on (b)(6) 2026 and last titrated from 4.0mA to 7.0mA on (b)(6) 2026. On (b)(6) 2026 the patient experienced itching at the chest pocket. In the early morning of (b)(6) 2026 the patient was shocked by their EVICD. The patient saw the ICD physician and was discharged. In the evening of (b)(6) 2026 the patient received another shock from their ICD and went to the emergency room where the ICD was turned off. Barostim was reduced to 4.0mA and the ICD was turned back on and the patient was allowed to go home. It was confirmed there were no precipitating factor that led up to the shocks and there were no issues with stimulation. At a titration appointment on (b)(6) 2026 the Barostim settings were tested at 4.0mA, 5.0mA, and 6.0mA and no oversensing was observed from the ICD. The physician requested the amplitude be left at 5.0mA. Per the physician the ICD shocks were due to oversensing of Barostim. The patient was reported to be stable and doing well.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50508841 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  A Barostim system was implanted on (b)(6) 2026. On (b)(6) 2026, the patient experienced fluid coming out of the incision. On (b)(6) 2026, the patient presented to the emergency room where they were admitted for an infection. It was noted that the incision was partially open and the patient was administered oral and intravenous antibiotics. The patient reported that it was a skin infection and they were discharged on (b)(6) 2026. The root cause of the infection was not stated by the emergency room physician. On 30-Jul-2026, the patient's incision was cleaned, and it was noted that it looked good. The patient's therapy was titrated, and it was reported that they were walking more and doing more things. As of (b)(6) 2026, it was reported that the patient completed the prescribed course of antibiotics, and the infection has since been resolved.

  Patient problems: Fluid Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50476799 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  A Barostim system was implanted on (b)(6) 2022, and a normal IPG replacement occurred on (b)(6) 2026. Following the procedure, the patient experienced a slight hematoma. Per the opinion of the physician, the root cause of the Hematoma was the procedure for the battery change. On (b)(6) 2026, the hematoma was drained and it was noted that the patient was stable. As of (b)(6) 2026, it was confirmed that the hematoma resolved.

  Patient problems: Hematoma

  MAUDE report 50476552 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  A Barostim system was implanted on (b)(6) 2023 and an IPG replacement occurred on (b)(6) 2026. It was noted that the incision looked good at discharge and the patient confirmed during a 24-hour check call that everything looked okay. On (b)(6) 2026, during the patient's one week follow up, the pocket looked infected, and the patient was advised to go to the emergency room. The incision was red, draining, and part of the incision had been dehisced. Cultures were taken and the result was positive for Staphylococcus epidermidis. The patient was administered oral antibiotics. A revision was done, and the pocket was debrided, cultures were taken and it was closed. The root cause of the infection was not disclosed by the physician. As of (b)(6) 2026, the patient continued to report symptoms of infection. On (b)(6) 2026, the device was explanted.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 50431751 ↗
• InjuryAug 24, 2026Use of Device Problem

  A Barostim system was implanted on (b)(6) 2025. On (b)(6) 2025, the patient reported issues with healing around the pocket location. It was noted that the wound had healed, but there was slight swelling. It was noted that prior to the wound healing there was some fluid drainage that had been present. There were also significant impedance changes that occurred between (b)(6) 2025 and (b)(6) 2025. An x-ray was performed, but results were not shared. As of (b)(6) 2025, no additional intervention was planned. In the opinion of the physician, the wound complaints were due to the patient "picking" at the wound site. The patient's device was successfully explanted on (b)(6) 2026 and there were no plans to reimplant the patient.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 50408033 ↗
• InjuryJul 27, 2026Defibrillation/Stimulation Problem

  A Barostim system was implanted on (b)(6) 2025 and last titrated from 6.0 to 7.0mA on (b)(6) 2026. ICD shocks occurred on (b)(6) 2026. ICD adjustments were made on (b)(6) 2026, and the electrophysiologist reported the event was caused or contributed to by Barostim. It was noted the patient had a complicated history that included Non-Ischemic Cardiomyopathy, prior VT ablation, prior SCD, AF/atrial tach, HF, and inoperable bladder diverticulum. It was also reported that the patient was a competitive triathlete, played tennis, and was very active after his HF diagnosis almost 20 years ago. The patient was still biking and swimming vigorously. The patient was seen for a follow up on (b)(6) 2026, and their therapy was reduced from 7.0mA to 1.0mA at the request of the physician. There was a plan to work with the Abbott rep, and physician to find a programming where the ICD and the Barostim can coexist safely.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50015469 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2024, AND LAST TITRATED ON (B)(6) 2026 WHERE THERAPY AMPLITUDE WAS INCREASED FROM 12.6MA TO 14.0MA. FOLLOWING THE TITRATION, THE PATIENT EXPERIENCED BUZZING IN THEIR NECK AS WELL AS DIZZINESS AND LIGHTHEADEDNESS. ON (B)(6) 2026 THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT FOR HF EXACERBATION. THE ROOT CAUSE OF THE EXACERBATION WAS NOT STATED BY THE PHYSICIAN. WHILE ADMITTED, THE PATIENT'S THERAPY WAS DISABLED, AND THE BUZZING IN THEIR NECK RESOLVED BUT THE DIZZINESS AND LIGHTHEADEDNESS PERSISTED. THE PATIENT'S THERAPY WAS REACTIVATED WITH THE THERAPY SET TO 9.4MA, AND THE STIM IN THE NECK REMAINED RESOLVED. ON (B)(6) 2026, THE PATIENT WAS DISCHARGED.

  Patient problems: Dizziness; Undesired Nerve Stimulation

  MAUDE report 25519756 ↗
• InjuryMay 27, 2026Device Dislodged or Dislocated

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025 AND LAST TITRATED FROM 3.8 TO 6.2MA ON (B)(6) 2026. STARTING ON (B)(6) 2026, THE PATIENT EXPERIENCED A "FLUTTER" NEAR THE IPG SITE WITHOUT PAIN OR DISCOMFORT. IT WAS ALSO NOTED THAT THE IPG HAD ALMOST FLIPPED. DEVICE INTERROGATION OCCURRED ON (B)(6) 2026, IMPEDANCE TRENDS WERE STABLE, AND BAROSTIM THERAPY WAS NOT CHANGED. CHEST AND NECK X-RAYS SHOWED THE CSL OVERLYING THE IPG INSTEAD OF THE EXCESS LEAD BEING LOCATED LATERALLY TO THE IPG. THE POSITIONING OF THE LEAD WAS SUGGESTIVE OF DEVICE MIGRATION, AND APPROPRIATE INTERVENTION WAS BEING ASSESSED. IN THE OPINION OF THE PHYSICIAN, WHILE THE ROOT CAUSE WAS UNABLE TO BE CONCLUSIVELY DETERMINED, THE PATIENT'S ANATOMY, PARTICULARLY THEIR HEAVIER CHEST, AND MOBILITY MAY HAVE CONTRIBUTED. A POCKET REVISION OCCURRED ON (B)(6) 2026, AND TWO SUTURES WERE STILL ATTACHED TO THE IPG AND WERE REQUIRED TO BE CUT. THE IPG WAS PLACED SUBMUSCULARLY WITH THE EXCESS CSL PLACED ABOVE IN THE ORIGINAL POCKET. THERE WAS NO CONTACT WITH THE IPG AND EXCESS LEAD, AND IMPEDANCE REMAINED STABLE THROUGHOUT THE PROCEDURE. AS OF 26-MAY-2026, THE PATIENT WAS DOING WELL WITH NO CONTINUING "FLUTTER" REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25302314 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. AS OF (B)(6) 2026, IT WAS REPORTED THE POCKET HAD "OPENED UP," BUT NO ADDITIONAL SYMPTOMS WERE REPORTED. IT WAS UNKNOWN WHEN SPECIFICALLY, THE PATIENT BEGAN EXPERIENCING THE ISSUE. A WASHOUT OF THE POCKET OCCURRED ON (B)(6) 2026. A CULTURE WAS PERFORMED, WAS POSITIVE FOR INFECTION, BUT SPECIFIC RESULTS WERE NOT SHARED. A PROCEDURE OCCURRED ON (B)(6) 2026. THE IPG WAS REPLACED, AND THE IPG WAS PLACED SUBMUSCULARLY. AS OF (B)(6) 2026, THE PATIENT WAS DOING WELL. IN THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE INFECTION WAS RELATED TO THAT SURGICAL PHYSICIAN ASSISTANTS HAD BEEN CLOSING SURGICAL INCISIONS, AND RETRAINING OF THE PHYSICIAN ASSISTANTS WAS OCCURRING BY THE SURGEON.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 25193666 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. IT WAS NOTED THERE WERE BRIEF PERIODS OF BRADYCARDIA DURING IMPLANT THAT WERE NOT OF CONCERN TO THE SURGEON OR ANESTHESIOLOGIST. LATER THAT DAY, THE PATIENT HAD EXPERIENCED A CODE BLUE AND WAS UNRESPONSIVE. AN MRI WAS PLANNED. IT WAS NOTED THE PATIENT WOKE APPROXIMATELY FIVE DAYS AFTER IMPLANT.

  Patient problems: Cardiac Arrest

  MAUDE report 25191642 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. PER THE REQUEST OF THE ANESTHESIA, THERAPY WAS DISABLED. THE PATIENT PASSED AWAY ON (B)(6) 2026.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25095352 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. AROUND ON (B)(6) 2026, THE PATIENT EXPERIENCED A HEMATOMA. (B)(6) 2026, THE PATIENT PRESENTED WITH SWELLING AND LEAKING AT THE CHEST POCKET. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS THE PATIENT'S REQUIREMENT FOR MEDICATION DUE TO HEMOPHILIA. THE PATIENT WAS SEEN FOR A FOLLOW UP ON (B)(6) 2026, FOR A POCKET CLEAN OUT. THE HEMATOMA WAS REMOVED AND THE PATIENT HAD NO FURTHER COMPLAINTS.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 25083034 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. THE PATIENT EXPERIENCED AN INFECTION AND DEHISCENCE AT THE CHEST POCKET STARTING ON (B)(6) 2026 AND WAS HOSPITALIZED ON (B)(6) 2026. CULTURES SHOWED PROTEUS MIRABILIS, AND THE PATIENT RECEIVED IV ANTIBIOTICS WHILE HOSPITALIZED. IN THE OPINION OF THE PHYSICIAN, BASED ON THE CULTURE RESULTS, THE INFECTION WAS BELIEVED TO BE RELATED TO A URINARY TRACT INFECTION, AND IT WAS ALSO NOTED THE PATIENT HAD BEEN APPLYING VITAMIN E OINTMENT TO THEIR INCISION PRIOR TO HOSPITALIZATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2026 WITH ORAL ANTIBIOTICS PRESCRIBED THROUGH (B)(6) 2026. AS OF (B)(6) 2026, THERE WAS NO FURTHER ISSUE OBSERVED WITH AN INFECTION OR DEHISCENCE.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 24941935 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025. FOLLOWING IMPLANT, THE PATIENT EXPERIENCED PAIN AT THE CHEST INCISION SITE AND THE IPG WAS STICKING OUT OF THEIR SKIN AND CAUSING DISCOMFORT. THEY ALSO EXPRESSED CONCERN WITH THE STIMULATION THEY FELT WHEN THERAPY LEVELS WERE ADJUSTED AND STATED IT FELT LIKE THEY WERE BEING ELECTROCUTED WITH EVERY ADJUSTMENT. THE PATIENT WAS ALSO CONCERNED THAT THEIR LEAD DID NOT HAVE THE APPROPRIATE POINTS OF CONTACT ON THEIR CAROTID. IT WAS NOTED THAT THE IMPEDANCE LEVELS COMPLIED AND AN ULTRASOUND AND CT LOOKED GOOD AS WELL. PER THE OPINION OF THEIR PREVIOUS PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS THAT THE IPG WAS NOT IMPLANTED DEEP ENOUGH IN THE CHEST WALL. THE PATIENT WAS SEEN FOR A CONSULTATION ON (B)(6) 2026, TO DISCUSS A POSSIBLE REVISION, AND ON (B)(6) 2026, THE PATIENT UNDERWENT A LEAD AND POCKET REVISION AND THE IPG WAS REPLACED. THEY REPORTED FEELING MUCH BETTER FOLLOWING THE REVISION. THEY WERE SEEN FOR A FOLLOW-UP ON (B)(6) 2026 WITH NO FURTHER COMPLAINT, AND ALL THE PATIENT'S SYMPTOMS WERE RESOLVED.

  Patient problems: Discomfort; Undesired Nerve Stimulation

  MAUDE report 24931601 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT EXPERIENCED BLEEDING FROM THE CHEST POCKET SITE AND PRESENTED TO THE EMERGENCY ROOM WHERE THEY WERE ADMITTED. A WOUND REVISION AND A HEMATOMA WASH OUT WAS DONE AND THE WOUND WAS CLOSED BY PLASTIC SURGERY. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2026. PER THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS THAT THE PATIENT WAS ON ANTICOAGULANTS WHICH LED TO BLEEDING FROM THE SURGICAL SITE. THE PATIENT WAS SEEN FOR A FOLLOW UP ON (B)(6) 2026 AND IT WAS CONFIRMED THAT THE HEMATOMA RESOLVED AND THE WOUND WAS COMPLETELY HEALED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24820845 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. FOLLOWING IMPLANT, THE PATIENT EXPERIENCED INCREASED SWELLING AND PAIN AT THE INCISION SITES AND HAD TO REMAIN IN THE HOSPITAL. THE PATIENT RECEIVED PAIN MEDICATION AND WAS DISCHARGED ON (B)(6) 2026. AS OF (B)(6) 2026, THE SYMPTOMS WERE RESOLVED.

  Patient problems: Discomfort; Swelling/ Edema

  MAUDE report 24728871 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2026. AROUND (B)(6) 2026, THE PATIENT EXPERIENCED THEIR IPG MOVING AROUND IN THE POCKET AND CAUSING A SHARP PAIN. THE PATIENT WAS ADVISED TO GET AN X-RAY. PER THE PHYSICIAN, THE ROOT CAUSE OF THE EVENT WAS UNKNOWN AS THE DEVICE WAS PLACED PERFECTLY WITH 6 SUTURES ON LEAD, 2 ON TAB AND 2 ON THE IPG. ON (B)(6) 2026, A SUCCESSFUL POCKET REVISION WAS DONE, AND THE DEVICE WAS PLACED SUB MUSCULARLY. AS OF (B)(6) 2026, THE PAIN RESOLVED AND THE PATIENT REPORTED DOING MUCH BETTER.

  Patient problems: Discomfort

  MAUDE report 24728383 ↗
• InjuryMar 30, 2026Device Dislodged or Dislocated

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2025, AND TWO SUTURES WERE USED IN FASCIA TO ANCHOR THE IPG. THE PATIENT BEGAN EXPERIENCING TENDERNESS AND SWELLING NEAR THE IPG POCKET ON (B)(6) 2026. THE PATIENT VISITED THE EMERGENCY ROOM ON (B)(6) 2026 AND WAS TOLD EVERYTHING LOOKED FINE. IT WAS NOTED NO VASCULAR OR HEART FAILURE PHYSICIANS OR CVRX WAS CONTACTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 FOR A DEVICE/IMPLANT COMPLICATION. IMAGING WAS OBTAINED, AND IT APPEARED THE SLACK IN THE CSL LEAD WAS NO LONGER PRESENT. A PROCEDURE WAS PERFORMED ON (B)(6) 2026. IT WAS NOTED THAT THE ORIGINAL IPG SUTURES WERE NO LONGER ATTACHED, AND, IN THE OPINION OF THE PHYSICIAN, THE STRESS CAUSED THE STRAIN RELIEF TAB TO DISCONNECT AS WELL. IN THE OPINION OF THE PHYSICIAN, THE PATIENT EITHER MANIPULATED THE IPG OR THE SUTURE KNOTS CAME LOOSE. A POCKET WASHOUT, IPG REPLACEMENT AND PLACEMENT IN ANTIBACTERIAL POUCH, AND LEAD REVISION TO RECREATE THE STRAIN LOOP OCCURRED. CULTURES SHOWED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) PRESENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2026, AND THE PAIN AND SWELLING HAD RESOLVED AT DISCHARGE. THE PATIENT WAS TO RECEIVE IV ANTIBIOTICS FOR

  Patient problems: Implant Pain; Medical device site infection; Swelling/ Edema

  MAUDE report 24718425 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (b)(6) 2024, AND ON (b)(6) 2025, THE PATIENT'S THERAPY WAS INCREASED FROM 6.0MA TO 7.0MA. AROUND (b)(6) 2025, THE PATIENT EXPERIENCED PACEMAKER INHIBITION DUE TO RV LEAD OVERSENSING LEADING TO INHIBITION OF PACING FOR SEVERAL SECONDS. IT WAS NOTED THAT THE PATIENT EXPERIENCED SYNCOPE DURING THE INHIBITION EPISODES. THE ROOT CAUSE WAS UNKNOWN, AND IT WAS SUSPECTED TO BE DUE TO AN RV LEAD ISSUE OR BAROSTIM AND POSSIBLY BOTH. THE PHYSICIAN EXPRESSED CONCERN REGARDING THE BSX 0184 LEAD FUNCTION AND IT WAS NOTED THAT IMPEDANCE WAS NORMAL ON THE LEAD AND COILS. ON (b)(6) 2026, INTERACTION TESTING WAS COMPLETED FOR THE PACEMAKER AND BAROSTIM. TESTING REVEALED PACEMAKER INHIBITION AFTER INCREASING BAROSTIM OUTPUT FROM 7.0MA TO 15.0MA. BAROSTIM OUTPUT WAS REDUCED TO 6.0MA, AND THE RV SENSITIVITY WAS ADJUSTED FROM 1.0MV TO .50MV AND THE ISSUE RESOLVED. IT WAS SUSPECTED THAT THE CRTD DEVICE WAS PREVIOUSLY REPROGRAMMED DUE TO PACEMAKER INHIBITION. A COMPLETE FILE OF PROGRAMMING WAS REQUESTED AND RECEIVED ON (b)(6) 2026. THE FILE WAS REVIEWED AND LOOKED UNREMARKABLE.

  Patient problems: Syncope/Fainting

  MAUDE report 24654516 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. AROUND (B)(6) 2026, THE PATIENT WAS HOSPITALIZED DUE TO LOW BLOOD PRESSURE. THE PATIENT BELIEVED THAT THEIR LOW BLOOD PRESSURE WAS BEING CAUSED BY BAROSTIM. IT WAS NOTED THAT THE PATIENT HAD NOT SEEN BY THEIR PHYSICIAN SINCE MOVING TO A NURSING HOME AND THE NURSING HOME WAS IN CHARGE OF THEIR CARE AND UNFAMILIAR WITH BAROSTIM. IT WAS ALSO NOTED THAT THE PATIENT WAS DUE FOR A BATTERY CHANGE WHICH WAS SCHEDULED FOR (B)(6) 2026. AS OF (B)(6) 2026, THE PATIENT HAD NOT HAD THEIR BATTERY CHANGE AND WAS ADMITTED TO THE HOSPITAL FOR RESPIRATORY FAILURE. IT WAS NOTED THAT THE PATIENT WAS NON-COMPLIANT WITH THEIR MEDICATION AND MEDICAL CARE AND PER THE SURGEON THE PATIENT WAS BEING EVALUATED FOR HOSPICE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24605076 ↗