BAROSTIM NEO 2102Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00859144004432), received between Jul 15, 2021 and Apr 13, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Device-Device Incompatibility

  A PATIENT WITH AN EXISTING S-ICD HAD A BAROSTIM SYSTEM IMPLANTED ON (B)(6) 2022 WITH INTERACTION OBSERVED AT 8.0MA. THE PHYSICIAN WAS AWARE THAT THERE WAS A CONTRAINDICATION PER THE S-ICD IFU FOR THE BAROSTIM DEVICE, BUT THE PHYSICIAN DECIDED TO IMPLANT BAROSTIM ANYWAYS. BAROSTIM THERAPY HAD BEEN PROGRAMMED AT 6.0MA SINCE ON (B)(6) 2023, BUT NO INTERACTION TESTING WAS PERFORMED AT THAT TIME. IN 2024, DURING ROUTINE HEMODIALYSIS, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) ARREST THAT THE S-ICD FAILED TO DETECT. CARDIOPULMONARY RESUSCITATION AND EXTERNAL DEFIBRILLATION OCCURRED, AND SPONTANEOUS CIRCULATION WAS ACHIEVED. ELECTROGRAMS SHOWED HIGH-FREQUENCY ARTIFACTS SYNCHRONOUS WITH BAROSTIM THERAPY WHICH RESULTED IN THE VF BEING READ AS ATRIAL FIBRILLATION. ON (B)(6) 2024, BAROSTIM THERAPY WAS DECREASED TO 1MA AND S-ICD REPROGRAMMING OCCURRED. IT WAS NOTED THE PATIENT HAD NO LASTING EFFECTS FROM THE EVENT AND HAD RECOVERED. THREE MONTHS LATER, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA, WHICH WAS DETECTED BY THE S-ICD AND APPROPRIATELY SHOCKED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24861163 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022 AND HAD PACEMAKER REPLACEMENT ON (B)(6) 2025. AS OF (B)(6) 2025, THE PATIENT'S PACEMAKER SYSTEM WAS INFECTED. IT WAS NOTED THE BAROSTIM DEVICE WAS ALSO POSSIBLY INFECTED AS TWO RIGHT-SIDED PACING LEADS SHARED THE IPG POCKET. THE PATIENT HAD THE IPG AND CSL EXPLANTED ON (B)(6) 2025. AS OF (B)(6) 2026, THE PATIENT HAD HAD AN ICD IMPLANTED SINCE THE EXPLANT, HAD THEIR ANTIBIOTICS DISCONTINUED, AND WERE DOING WELL.

  Patient problems: Medical device site infection

  MAUDE report 24396888 ↗
• InjuryJul 18, 2025Unintended Movement; Unintended Movement

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. ON 2(B)(6) 2025, THE PATIENT WAS IN THE CARDIAC CARE UNIT FOR CHEST PAIN, AND THE PATIENT ALLEGED IT WAS RELATED TO BAROSTIM. THE PATIENT ALSO EXPERIENCED INCREASED EDEMA IN THEIR LEFT EXTREMITIES, AND A RIGHT HEART CATHETERIZATION WAS PLANNED. THE PATIENT ALSO REPORTED THEY EXPERIENCED SOME FACIAL DROOP AND RESTLESS LEG SYNDROME (RLS) SINCE APPROXIMATELY (B)(6) 2025 RELATED TO BAROSTIM, AND THE SYMPTOMS HAD SUBSIDED WHEN A MAGNET WAS PLACED ON BAROSTIM. THE PATIENT ALSO ALLEGED PART OF THE BAROSTIM HAD MIGRATED TO THEIR GROIN SHORTLY AFTER IMPLANT; HOWEVER, THEY NEVER REPORTED THIS ALLEGATION TO ANY PHYSICIAN, NO X-RAY WAS EVER PERFORMED, TITRATIONS HAD OCCURRED WITHOUT ISSUE, AND NO LEAD IMPEDANCE ISSUES WERE NOTED. IT WAS NOTED THAT BAROSTIM HAD LAST BEEN INTERROGATED IN (B)(6) 2023 WITH AN ANTICIPATED BATTERY LIFE THROUGH (B)(6) 2026. BAROSTIM THERAPY WAS TURNED OFF, IT WAS PLANNED TO MANAGE THE PATIENT'S MEDICATIONS AND DIURETICS FOR THE EDEMA, AND THE PATIENT NO LONGER HAD A MANAGING CARDIAC PHYSICIAN.

  Patient problems: Chest Pain; Facial Paralysis; Restless Legs Syndrome; Swelling/ Edema

  MAUDE report 22544180 ↗
• InjuryJun 13, 2025Expulsion; Expulsion

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. THE PATIENT EXPERIENCED DEVICE EROSION AT BOTH THE CSL AND IPG LOCATIONS IN EARLY 2025. THE IPG AND A PORTION OF THE CSL WERE EXPLANTED ON (B)(6) 2025. PER THE OPINION OF THE PHYSICIAN, THE PATIENT WAS NON-COMPLIANT AND MAY HAVE HAD TWIDDLER'S SYNDROME. IT WAS NOTED THE PATIENT RECOVERED FOLLOWING THE EXPLANT.

  Patient problems: Pocket Erosion; Twiddlers Syndrome

  MAUDE report 22202814 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. IN (B)(6) 2023, THE PATIENT EXPERIENCED COUGHING FITS DUE TO A VIRAL INFECTION AS WELL AS TIGHTNESS IN THEIR THROAT/A FOREIGN BODY SENSATION WHEN THEY BENT OVER AND PRESSURE AROUND THE SITE OF THE LEAD. AFTER A MORE VIOLENT COUGHING FIT, THE PATIENT WAS WORRIED THE LEAD HAD DISLODGED. A CT SCAN SHOWED THE LEAD AS EXPECTED. ON APPROXIMATELY (B)(6) 2023, THE COUGHING FITS SUBSIDED, BUT THE THROAT TIGHTNESS REMAINED PRESENT. IT WAS NOTED THAT BAROSTIM THERAPY WAS INCREASED OVER THIS TIME. ON (B)(6) 2023, THE THERAPY AMPLITUDE WAS REDUCED FROM 7MA TO 3MA. THE THROAT TIGHTNESS SUBSIDED. THE PATIENT STATED THEY FELT MUCH BETTER BUT WAS NOT SATISFIED WITH THE RESPONSE THEY RECEIVED FROM THEIR PHYSICIAN AND WAS ADVISED TO SEEK A SECOND OPINION. THE SECOND PHYSICIAN SUGGESTED THAT BASED ON THE EXISTING CT SCAN, THE STRAIN RELIEF LOOP WAS TOO BIG AND MAY BE PRESSING ON A PHARYNGEAL NERVE. THE PATIENT RETURNED TO THEIR ORIGINAL PHYSICIAN WITH THE INFORMATION AND THEIR THERAPY WAS TURNED OFF. WHILE THE THERAPY WAS OFF, THE PATIENT EXPERIENCED INCREASED HF SYMPTOMS, INCLUDING FLUID RETENTION. THE FOREIGN BODY SENSATION WAS NOT RESOLVED BUT THE PAT

  Patient problems: Discomfort; Undesired Nerve Stimulation

  MAUDE report 21986765 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6)2024. ON (B)(6)2024, THE PATIENT WAS SEEN FOR WHAT THEY THOUGHT WAS A POCKET OF PUS. IT WAS DETERMINED THAT THE PATIENT HAD A CYST AND ON (B)(6)2024, A PROCEDURE WAS PERFORMED TO REMOVE IT. PER THE OPINION OF THE PHYSICIAN, THERE WAS A SMALL SEROMA AND THE FLUID WAS EVACUATED. THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS PRE-OPERATION AND THE POCKET WAS IRRIGATED. THE PATIENT WAS STABLE AND WAS DISCHARGED HOME ON THE SAME DAY. ON (B)(6)2024, THE PATIENT WAS SEEN FOR A FOLLOW-UP. THE PATIENT WAS DOING GREAT AND PRESENTED WITH ZERO COMPLAINTS.

  Patient problems: Cyst(s)

  MAUDE report 20534308 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. THE PATIENT EXPERIENCED PULMONARY EDEMA AND RIGHT PLEURAL EFFUSION RELATED TO THE PROCEDURE ON (B)(6) 2023, AND FLUID WAS REMOVED. IT WAS NOTED THAT THE PATIENT SHOWED THE SAME PLEURAL EFFUSION ON (B)(6) 2023, THREE DAYS PRIOR TO THE BAROSTIM IMPLANT. ON (B)(6) 2023, THE PATIENT REPORTED BEING SICK AND SPITTING UP PHLEGM. A FOLLOW-UP APPOINTMENT WAS SCHEDULED ON (B)(6) 2023 WHICH WAS POSTPONED FOR AN UNRELATED ISSUE. AS OF (B)(6) 2023, THE PATIENT WAS DOING WELL. IN THE OPINION OF THE PHYSICIAN, THE PHLEGM WAS RELATED TO A PRE-EXISTING PATIENT CONDITION AND WAS NOT RELATED TO BAROSTIM THERAPY.

  Patient problems: Pleural Effusion; Pulmonary Edema

  MAUDE report 19721786 ↗
• InjuryMar 22, 2024Unintended Movement; Unintended Movement

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT REPORTED THAT FOLLOWING THE IMPLANT, THEY EXPERIENCED PAIN IN THEIR NECK, NUMBNESS TO THEIR EARS AND SWELLING. THE PATIENT WAS SCHEDULED TO BE SEEN ON (B)(6) 2023. ON (B)(6) 2023, THERAPY WAS TEMPORARILY TURNED OFF TO SEE IF THE PATIENT FELT PAIN WITH THE THERAPY OFF. THE PATIENT CONTINUED TO FEEL THE SAME PAIN, AND THE THERAPY WAS RESUMED. THE PHYSICIAN ESTABLISHED THAT THE PATIENT WAS EXPERIENCING NORMAL SURGICAL PAIN AND INSTRUCTED THE PATIENT TO TAKE ADVIL FOR THE PAIN. AS OF (B)(6) 2024, THE PATIENT REPORTED STILL EXPERIENCING NUMBNESS IN THEIR LOWER EAR LOBE THAT EXTENDS DOWN TO THEIR NECK AND PAIN AT THE IPG SITE AS WELL AS HAVING TO HOLD THE DEVICE TO TURN AT NIGHT. THE PATIENT MENTIONED THAT AS A SINGER, THE NUMBNESS WAS PREVENTING THEM FROM SINGING IN TUNE. THE PATIENT WAS SCHEDULED TO BE SEEN ON (B)(6) 2024. A CHEST X-RAY WAS ORDERED, AND THE DEVICE WAS TURNED OFF. THE X-RAY CONFIRMED THAT THE DEVICE WAS NOT FLIPPED BUT THE LEAD WAS IN AN INTERESTING POSITION. THE PHYSICIAN CONFIRMED THAT THE LEAD WAS LOOPED THAT WAY ON PURPOSE BECAUSE OF THE PATIENT'S SMALL FRAME AND THAT THE ASSUMED MOVEMENT OF

  Patient problems: Choking; Implant Pain; Numbness; Swelling/ Edema; Undesired Nerve Stimulation

  MAUDE report 18960522 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. THE PATIENT REPORTED SORENESS AROUND INCISION AREA ON (B)(6) 2023. WHEN THEY WOKE UP ON (B)(6) 2023, THE NECK INCISION WAS WARM TO THE TOUCH AND SWOLLEN. THE PATIENT DID NOT REPORT A FEVER. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023. THE PATIENT WAS DIAGNOSED WITH CELLULITIS. THE POCKET WAS FLUSHED ON (B)(6) 2023, AND IT WAS NOTED THE IPG WAS FREE FLOATING IN THE POCKET. IT WAS NOTED THAT THE IPG HAD BEEN SUTURED WITH TWO SUTURES AT THE INITIAL IMPLANT. CULTURES WERE POSITIVE FOR STREP A. THE POCKET WAS IRRIGATED AGAIN ON (B)(6) 2023, AND THE IPG WAS REPLACED. THE NEW IPG WAS PLACED SUB-PECTORALLY IN AN ANTIBACTERIAL POUCH, A WOUND VAC WAS PLACED AND THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON AN UNKNOWN DATE. AS OF (B)(6) 2023, THE WOUND VAC HAD BEEN REMOVED AS THERE WAS NO FURTHER DRAINAGE FROM THE INCISION, THE INCISION SITE WAS HEALING, AND THE PATIENT WAS DOING WELL. AN APPOINTMENT WAS SET FOR (B)(6) 2023 TO ASSESS IF THE ANTIBIOTICS SHOULD BE CONTINUED.

  Patient problems: Cellulitis; Post Operative Wound Infection

  MAUDE report 17969108 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT REPORTED INCREASED SHORTNESS OF BREATH AND FATIGUE, AND BAROSTIM THERAPY WAS INCREASED. ON (B)(6) 2023, THE PATIENT EXPERIENCED INCREASED SHORTNESS OF BREATH. DUE TO THE SHORTNESS OF BREATH, THE PATIENT WAS SELF-DOSING WITH LASIX. LABS WERE PERFORMED, AND LASIX WAS DISCONTINUED DUE TO CARIOMEMS NUMBERS. ON (B)(6) 2023, THE PATIENT WAS IN DISTRESS AND DIRECTLY ADMITTED TO THE INTENSIVE CARE UNIT DUE TO CARDIOGENIC SHOCK. A RIGHT HEART CATHETERIZATION (RHC) WAS PERFORMED, AND RESULTS SHOWED ELEVATED PULMONARY ALVEOLAR PROTEINOSIS (PAP). INOTROPES WERE ADMINISTERED. THORACENTESIS WAS PERFORMED ON (B)(6) 2023, AND 850ML OF FLUID WAS REMOVED. KIDNEY FUNCTION WAS REPORTED TO BE WORSENING. LUNG ARTERIAL PRESSURE WERE INDICATIVE OF HYPOVOLEMIA ON (B)(6) 2023, AND MILRINONE WAS DISCONTINUED WITH VOLUME BOLUSES ADMINISTERED. BAROSTIM THERAPY WAS DECREASED FROM 9.4 MAS TO 5.0 MAS. DOBUTAMINE WAS ADMINISTERED, AND PLEURAL FLUID RETURNED. BILATERAL CHEST TUBES WERE PLACED ON (B)(6) 2023, AND FILLING PRESSURES WERE REPORTED TO BE LOW. THE PATIENT WAS HYPERTENSIVE, AND HIGH DOSE STEROIDS WERE ADMINISTERED. THE PATIENT WAS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiogenic Shock; Electrolyte Imbalance; Fatigue; High Blood Pressure/ Hypertension; Pulmonary Edema; Renal Failure

  MAUDE report 17756732 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT REPORTED EXPERIENCING WORSENING HF SYMPTOMS, LOW BLOOD PRESSURE, AND DIZZINESS SINCE THEIR LAST TITRATION ON (B)(6) 2023. THE PATIENT'S BLOOD PRESSURE ON (B)(6) 2023 WAS 95/59. DURING DEVICE PROGRAMMING, THE PATIENT BECAME DIZZY AND EXPERIENCED LOW BLOOD PRESSURE OF APPROXIMATELY 80/40 TO 75/40. IT WAS NOTED THE PATIENT'S HEARTBEAT MAY HAVE BEEN IRREGULAR, AND THE BAROSTIM DEVICE WAS TURNED OFF FOR AN EKG. THE EKG SHOWED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS. WHILE AWAITING TRANSPORT TO THE EMERGENCY DEPARTMENT, THE PATIENT'S BLOOD PRESSURE IMPROVED TO 100+/70+, AND THE PREMATURE VENTRICULAR CONTRACTIONS WERE NO LONGER OCCURRING. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) TO (B)(6). DURING HOSPITALIZATION, IT WAS FOUND THAT THERE WAS A 60-70% BLOCKAGE IN A PREVIOUSLY STENTED HEART VESSEL, AND THE PATIENT HAD LOW POTASSIUM. MEDICATIONS WERE ADJUSTED AND A LATER HEART INTERVENTION WAS PLANNED BUT NOT SCHEDULED. IT WAS NOTED THE PATIENT'S ICD WAS NOT CHECKED DURING THE HOSPITALIZATION. THE PATIENT NOTED FEELING IMPROVED WHEN POTASSIUM WAS ADMINISTERED IN THE HOSPITAL. BAROSTIM THERAPY WAS RESTA

  Patient problems: Arrhythmia; Dizziness; Heart Failure/Congestive Heart Failure; Hypokalemia; Low Blood Pressure/ Hypotension

  MAUDE report 17735751 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2021. THE PATIENT EXPERIENCED "ANNOYING SIDE EFFECTS," AND THE IPG AND LOWER PORTION OF THE CSL WERE EXPLANTED ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphagia/ Odynophagia; Sore Throat

  MAUDE report 17085551 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. IN (B)(6) 2022, THE PATIENT STARTED TO EXPERIENCE SYNCOPE. IT WAS NOTED THAT THE PATIENT EXPERIENCED SYNCOPE APPROXIMATELY SEVEN TIMES. A DUAL CHAMBER ICD WAS PLACED ON (B)(6) 2023, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THERE WERE NO ADJUSTMENTS MADE TO THE BAROSTIM SYSTEM. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE SYNCOPE OR DETERMINE IF THE BAROSTIM SYSTEM WAS CONTRIBUTORY. IT WAS NOTED THAT THE PATIENT HAD MULTIPLE PHYSICIANS CHANGING THEIR MEDICATIONS WITHOUT COMMUNICATION OR CONSULT WITH THEIR CARDIOLOGIST AND THE PATIENT HAD EXPERIENCED INSTANCES OF DEHYDRATION.

  Patient problems: Syncope/Fainting

  MAUDE report 16962209 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT EXPERIENCED A HEADACHE. THEY WERE STARTED ON FIORICET, AND HAD AN APPOINTMENT WITH THEIR NEUROLOGIST. AS OF ON (B)(6) 2023, THE HEADACHE HAD RESOLVED. THE OPINION OF THE BAROSTIM PHYSICIAN WAS THAT THE HEADACHE WAS RELATED TO THE BAROSTIM SYSTEM. THE PATIENT HAD BEEN HOSPITALIZED FOR HEART FAILURE DECOMPENSATION, INCLUDING SHORTNESS OF BREATH, ON (B)(6) 2023. WHILE HOSPITALIZED, THE PATIENT WAS COMPENSATED WITH MEDICATIONS, AND THE BAROSTIM SYSTEM THERAPY WAS INCREASED. THE PATIENT WAS RELEASED ON (B)(6) 2023. IT WAS NOT KNOWN IF THE HOSPITALIZATION OR HEART ISSUES WERE RELATED TO THE BAROSTIM SYSTEM OR THERAPY. THE PATIENT WAS PLACED ON THE TRANSPLANT LIST. AS OF ON (B)(6) 2023, IN THE OPINION OF THE PHYSICIAN, THE ROOT CAUSE OF THE PATIENT'S HOSPITALIZATION WAS DECOMPENSATION RELATED TO THEIR PRE-EXISTING HEART FAILURE AND WAS NOT CAUSED OR CONTRIBUTED TO BY THE BAROSTIM SYSTEM. AS OF ON (B)(6) 2023, THE PATIENT WAS DOING WELL.

  Patient problems: Headache; Unspecified Heart Problem

  MAUDE report 16815922 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2023. TWO WEEKS AFTER IMPLANT, A FOLLOW-UP OCCURRED, AND THE STITCHES LOOKED GOOD, BUT THE AREA AROUND THE POCKET INCISION WAS INFLAMED. THE PATIENT WAS STARTED ON ORAL ANTIBIOTICS. THE PATIENT RETURNED TWO WEEKS LATER FOR "STITCHES" REMOVAL, AND THE POCKET INCISION WAS STILL INFLAMED. THE PATIENT WAS PRESCRIBED OVER THE COUNTER CREAM AND INSTRUCTED TO FINISH THEIR COURSE OF ANTIBIOTICS AND RETURN IN TWO WEEKS FOR WOUND CLEANING. ON (B)(6) 2023, THE POCKET WAS OPENED, AND THE AREA WAS CLEANED USING CAUTERY AND SALINE SOLUTION. A PORTION OF TISSUE WAS REMOVED WITH THE CAUTERY. THE PHYSICIAN STATED THAT THE AREA REMOVED WAS PROBABLY ISCHEMIC AS A PORTION OF SKIN MAY HAVE BEEN HIGHER ON ONE SIDE WHEN DOING THE STITCHES, CAUSING AN ISCHEMIC EVENT. THE REMOVED TISSUE WAS NOT SENT FOR CULTURE. NO PUSS-LIKE FLUID WAS OBSERVED. ADDITIONAL ORAL ANTIBIOTICS WERE PRESCRIBED. AT FOLLOW-UP APPOINTMENT ON (B)(6) 2023, THE INFECTION HAD CLEARED, STITCHES WERE REMOVED, AND THE PATIENT WAS DOING WELL.

  Patient problems: Inflammation; Ischemia

  MAUDE report 16615057 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT EXPERIENCED REDNESS AND SWELLING AT THE POCKET SITE. ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN AND SWELLING, AND THE IPG POCKET WAS OPEN BUT THE IPG WAS NOT EXPOSED. A DEVICE EXPLANT WAS PERFORMED ON (B)(6) 2022, AND THE CSL REMAINED IN VIVO. THE IPG WAS SENT TO PATHOLOGY FOR ANALYSIS, AND ANALYSIS RESULTS WERE UNAVAILABLE. THE PATIENT WAS RELEASED ON (B)(6) 2022, AND, AS OF (B)(6) 2022, THE PATIENT WAS DOING WELL WITH THE INFECTION RESOLVED. PER THE PHYSICIAN, THE ROOT CAUSE OF THE INFECTION WAS UNABLE TO BE DETERMINED.

  Patient problems: Erythema; Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 15923277 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT EXPERIENCED SYMPTOMS OF AN INFECTION, INCLUDING PUS DRAINING FROM THE POCKET SITE. THE PATIENT WAS STARTED ON ORAL ANTIBIOTICS, AND AN EXPLANT WAS SCHEDULED. THE SYSTEM WAS REMOVED ON (B)(6) 2022, AND THE INFECTION WAS LIMITED TO THE CHEST POCKET. THERE WERE NO SIGNS OF INFECTION IN THE NECK, AND THE LEAD HAD BEEN VERY WELL INCORPORATED. THE PATIENT WAS STARTED ON INTRAVENOUS ANTIBIOTICS, AND WAS DOING WELL POST-OP. CULTURES OF THE INFECTION SHOWED STAPHYLOCOCCUS AUREUS. IN THE OPINION OF THE PHYSICIAN, THE INFECTION ORIGINATED DUE TO THE FACT THAT THE PATIENT HAD TWO BAD TEETH, AND THE POCKET INFECTION WAS SEEDED FROM THE BAD TEETH. AS OF (B)(6) 2022, THE PATIENT HAD BEEN DISCHARGED APPROXIMATELY TWO OR THREE WEEKS PRIOR AND HAD COMPLETED THEIR INTRAVENOUS COURSE OF ANTIBIOTICS. THE PATIENT WAS REPORTED TO BE DOING WELL AT THEIR LAST FOLLOW-UP THE WEEK OF (B)(6) 2022.

  Patient problems: Bacterial Infection

  MAUDE report 15379204 ↗
• InjuryAug 19, 2022Unintended System Motion; Insufficient Device Problem Information; Migration; Unintended System Motion; Insufficient Device Problem Information; Migration

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2022, THE PATIENT REPORTED THEY EXPERIENCED LEAD PULLING AND LIMITED RANGE OF MOTION IN THEIR NECK, WHICH RESULTED IN PAIN. THE PATIENT ALSO EXPERIENCED IPG MOVEMENT IN THE CHEST. X-RAYS WERE PERFORMED, AND NOTHING UNUSUAL WAS NOTED. A LEAD REVISION WAS PERFORMED ON (B)(6) 2022. THE PHYSICIAN OPENED THE NECK INCISION AND OBSERVED THE STRAIN RELIEF LOOP WAS IN PLACE. ADDITIONAL LEAD WAS ALSO PULLED UP FROM THE POCKET INTO THE NECK, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2022, THE PATIENT REPORTED THE ISSUE WAS UNCHANGED, AND THEY STILL EXPERIENCED LEAD PULLING. THE PHYSICIAN STATED THERE WAS SLACK IN THE LEAD THAT WAS OBSERVED DURING THE PROCEDURE. THE PHYSICIAN RECOMMENDED THE PATIENT STRETCH THEIR NECK REGULARLY TO MANIPULATE THE SLACK. ON (B)(6) 2022, THE PATIENT PERFORMED SOME PHYSICAL ACTIVITY, AND FELT A POP IN THEIR NECK. A SMALL HEMATOMA WAS OBSERVED NEAR THE INCISION SITE ON (B)(6) 2022. THE OPINION OF THE PHYSICIAN WAS THAT AN INCISION SUTURE BROKE.

  Patient problems: Hematoma; Loss of Range of Motion; Neck Pain

  MAUDE report 15262469 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THERAPY WAS LEFT ACTIVATED AT 125/1/40. ON (B)(6) 2022 THE PATIENT EXPERIENCED A SYNCOPAL EPISODE DUE TO HICCUP INDUCED VOMITING. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022. NO DEVICE INTERVENTION WAS PERFORMED, AND THE PATIENT WAS MANAGED WITH MEDICATIONS. THE PATIENT WAS FULLY RECOVERED AND DISCHARGED HOME ON (B)(6) 2022. IN THE OPINION OF THE PHYSICIAN, THE HICCUP-INDUCED VOMITING AND SYNCOPE WAS PROCEDURALLY RELATED TO THE HIGH BIFURCATION OF THE PATIENT'S ANATOMY AND WAS NOT RELATED TO THE DEVICE.

  Patient problems: Hiccups; Syncope/Fainting; Vomiting

  MAUDE report 14705713 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DUE TO HEMATOMA AT THE POCKET SITE. IT WAS NOTED THAT THE PATIENT WAS TAKING AN ANTICOAGULANT MEDICATION. AN INFECTION CULTURE WAS PERFORMED, AND PROTEUS MIRABILIS WAS DETECTED. THE HEMATOMA SITE WAS EVACUATED, AND MODERATE OLD LIQUIFIED HEMATOMA WAS OBSERVED WITH NO GROSS SIGNS OF INFECTION. THE POCKET WAS IRRIGATED WITH SALINE WITH A FLOW SEAL, THE IPG WAS PLACED IN AN ABSORBABLE ANTIBIOTIC POUCH, AND ORAL ANTIBIOTICS WERE ADMINISTERED. THERAPY REMAINED ACTIVATED, AND THE PATIENT EXPERIENCED FUNCTIONAL IMPROVEMENT IN THEIR HEART FAILURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2022 WITH THE INFECTION CONTROLLED.

  Patient problems: Bacterial Infection; Hematoma

  MAUDE report 14690043 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE PATIENT EXPERIENCED A HEMATOMA AT THE POCKET SITE ON 11-MAY-2022 AND WAS ADMITTED TO THE HOSPITAL ON 12-MAY-2022. THE HEMATOMA WAS WASHED OUT, AND THERE WERE NO SIGNS OF INFECTION. THE PATIENT WAS DISCHARGED ON 13-MAY-2022. AT THE FOLLOW-UP APPOINTMENT ON 31-MAY-2022, THE PATIENT WAS DOING WELL.

  Patient problems: Hematoma

  MAUDE report 14577430 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BAROSTIM SYSTEM WAS IMPLANTED ON (B)(6) 2022. THE PATIENT DEVELOPED SYMPTOMS OF AN INFECTION, INCLUDING SWELLING AT THE NECK INCISION, AND WAS HOSPITALIZED ON (B)(6) 2022. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS FROM (B)(6) 2022 THROUGH (B)(6) 2022. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 ON ORAL ANTIBIOTICS, AND AN EXPLANT WAS SCHEDULED FOR (B)(6) 2022. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2022 IN PREPARATION FOR THE EXPLANT ON (B)(6) 2022. DURING THE PROCEDURE, THE POCKET WAS WASHED OUT, AND A CULTURE TAKEN. THE BAROSTIM SYSTEM WAS NOT EXPLANTED. THE PATIENT REMAINED HOSPITALIZED ON ANTIBIOTICS. CULTURE RESULTS CAME BACK AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA), AND A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE SYSTEM. AS OF (B)(6) 2022, THE PATIENT REMAINED HOSPITALIZED AND ON ANTIBIOTICS.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 14305602 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING IMPLANT OF THE BAROSTIM SYSTEM ON (B)(6) 2020, THE PATIENT EXPERIENCED CHRONIC PAIN AT THE DEVICE POCKET INCISION AND THE ELECTRODE INCISION IN THE NECK. A REFERRAL WAS MADE TO A PAIN SPECIALIST, BUT THE PAIN WAS NOT RESOLVED. THE PATIENT WAS UNWILLING TO TRY TO TURN OFF THERAPY FOR ONE TO TWO WEEKS. A SYSTEM EXPLANT WAS PERFORMED ON (B)(6) 2021. NO ISSUES OR COMPLICATIONS WITH THE DEVICE OPERATION WERE REPORTED.

  Patient problems: Implant Pain; Neck Pain

  MAUDE report 12481038 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED ON (B)(6) 2021 WITH THE BAROSTIM NEO SYSTEM. ON OR ABOUT (B)(6) 2021 THE PATIENT EXPERIENCED A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WHICH WAS MANAGED WITH NITROGLYCERIN AND DID NOT REQUIRE CATHETERIZATION. THE SURGEON AND CARDIOLOGIST ATTRIBUTED THIS TO THE ANESTHESIA REGIMEN FOR THE IMPLANT PROCEDURE. THE PATIENT WAS REPORTED TO HAVE AN EXTENSIVE CARDIAC HISTORY INCLUDING PAST NSTEMI EVENTS. PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2021 BUT NOT DUE TO THE NSTEMI. THIS WAS REPORTEDLY DUE TO ADDITIONAL SWELLING AT THE NECK INCISION SITE RELATED TO RESTARTING OF ANTICOAGULATION THERAPY SOON AFTER THE PROCEDURE. ALL EVENTS WERE REPORTEDLY ADDRESSED AND FELT TO RESOLVE QUICKLY WITH MEDICAL MANAGEMENT ON THE FLOOR AND DID NOT REQUIRE ADDITIONAL INVASIVE PROCEDURES. CVRX WAS NOT MADE AWARE OF THIS EVENT UNTIL (B)(6) 2021.

  Patient problems: Myocardial Infarction; Skin Inflammation/ Irritation

  MAUDE report 12177914 ↗