SJM™ RSAR-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734009447), received between Aug 9, 2021 and Oct 3, 2023 — classified as 1 death, 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM RIGID SADDLE RING WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, AFTER IMPLANTATION, TESTED FOR VALVE INSUFFICIENCY, THE REPAIR EFFECT WAS NOT AS EXPECTED, AND THE PHYSICIAN REMOVED THE SADDLE FORMING RING AND PERFORMED MITRAL VALVE REPLACEMENT WITH A 29MM BIOCOR TISSUE HEART VALVE. THE PHYSICIAN ALLEGED THAT THE FORMING EFFECT OF THE FORMING RING WAS NOT GOOD, RESULTING IN A LACK OF EFFICACY. THE DURATION OF THE PROCEDURE WAS EXTENDED, WITH THE PAUSE AND BODY CYCLE TIME EXTENDED BY 20 MINUTES. THE PATIENT IS STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17860547 ↗
• MalfunctionSep 29, 2023Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM RIGID SADDLE RING WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, AFTER IMPLANTATION, THE TEST STILL HAD REGURGITATION, THE REPAIR EFFECT DID NOT MEET EXPECTATIONS, AND THE PHYSICIAN REMOVED THE SADDLE FORMING RING AND PERFORMED MITRAL VALVE REPLACEMENT. THE PHYSICIAN ALLEGED THAT THE FORMING EFFECT OF THE FORMING RING WAS NOT GOOD, RESULTING IN A LACK OF EFFICACY. THE PROCEDURE WAS EXTENDED FOR 20 MINS, HOWEVER, THE PATIENT IS STABLE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17848401 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF EU2624-285 (B)(4). IT WAS REPORTED THAT ON 01 FEBRUARY 2023, A 30MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT HAD A COMPLETE ATRIOVENTRICULAR BLOCK AND A PERMEANT PACEMAKER WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT HAD A PERICARDIAL EFFUSION DURING REHABILITATION. ON (B)(6) 2023, THE PATIENT UNDERWENT RE-OPERATION.

  Patient problems: Heart Block; Pericardial Effusion

  MAUDE report 16478957 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM RIGID SADDLE RING WAS IMPLANTED. POST OPERATIVELY, AFTER BEING TAKEN OFF BYPASS, THE PATIENT HAD SEVERE BIVENTRICULAR DYSFUNCTION CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT REQUIRED ECMO SUPPORT TO LEAVE CPB AND A BRIDGING VENTRICULAR ASSIST DEVICE WAS PLACED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. NO PATIENT CONSEQUENCES WERE REPORTED. NO ALLEGATIONS OF MALFUNCTION WERE REPORTED WITH THE RING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 16467254 ↗
• InjuryFeb 16, 2023Material Separation; Material Separation

  CLINICAL STUDY PATIENT ID: (B)(6). EU1671 - 810 (R734972601, R734969801, R734974401, R734977801, R735456601, R735573301, R735570501, R735572601, R735571401, R737106901). IT WAS REPORTED THAT ON (B)(6) 2023 A 30MM RIGID SADDLE RING WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING SUTURED IN, THE HOLDER BECAME DISLODGED. THE RING WAS ABLE TO BE SUCCESSFULLY IMPLANTED IN THE PATIENT. POST PROCEDURE THE PATIENT HAD HEMODYNAMIC INSTABILITY, DISTRIBUTIVE SHOCK DUE TO DRAIN LEAKAGE (1700 ML) REQUIRING MILRINONE AND NORADRENALIN. THE PATIENT RECEIVED FRESH FROZEN PLASMA, PLATELETS, AND PACKED RED BLOOD CELLS. THE PATIENT HAD CARDIOGENIC SHOCK DUE TO RIGHT VENTRICULAR FAILURE. ON (B)(6) 2023, FIRST DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS REPORTED; NO TREATMENT WAS PROVIDED. ON (B)(6) 2023, ANEMIA WITH HEMOGLOBIN DECREASED FROM 5.5. TO 4.4 MMOL/L WAS OBSERVED AND 1 UNIT OF PACK RED BLOOD CELLS WAS TRANSFUSED. ON (B)(6) 2023, THE PATIENT HAD PLEURAL FLUID 4-5 CM REQUIRING DIURETICS. ON (B)(6) 2023, REOPERATION WAS PERFORMED AND THORAX DRAINS WERE PLACED TO DRAIN PLEURAL FLUID. BLEEDING AND CLOTS IN THE PERICARDIUM CAUSING CARDIOGENIC SHOCK WAS OBSERVED. THE PATIENT WA

  Patient problems: Anemia; Heart Block; Hemorrhage/Blood Loss/Bleeding; Pleural Effusion

  MAUDE report 16386676 ↗
• InjuryDec 28, 2022Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6).SUBSEQUENT TO THE PREVIOUSLY FILED REPORT , ADDITIONAL INFORMATION WAS RECEIVED THAT THERE HAD BEEN NO DIFFICULTY EXPERIENCED IMPLANTING THE 30MM RIGID SADDLE RING. ON (B)(6) 2022, IT WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM THAT DEHISCENCE OF THE 30MM RIGID SADDLE RING HAD OCCURRED DUE TO A CARDIAC TEAR. GRADE 3 MITRAL VALVE INSUFFICIENCY/REGURGITATION WAS ALSO NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM AND RESULTED IN CARDIAC DECOMPENSATION, DYSPNEA, AND A NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASS OF 3-4. THE DECISION WAS MADE SUCCESSFULLY TO EXPLANT THE 30MM RIGID SADDLE RING AND REPLACE IT WITH A 33MM EPIC VALVE. THE PATIENT WAS STABLE AT THE TIME OF REPORT. THE CARDIAC TEAR WAS DUE TO FRAILTY/WEAKNESS OF THE CARDIAC TISSUE. THE MITRAL VALVE INSUFFICIENCY/REGURGITATION WAS DUE TO THE RING DEHISCENCE. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE 30MM RIGID SADDLE RING OR PROCEDURE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16064183 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, PRIOR TO PROCEDURE, A PATIENT HAD DECOMPENSATION CORDIS. THEN, A 30MM RIGID SADDLE RING WAS IMPLANTED INTO THE PATIENT. PRIOR TO DISCHARGE, BUT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ISCHEMIA. 4CC OF MILRIONON PER HOUR WAS ADMINISTERED TO TREAT THE PATIENT. THE PATIENT IS REPORTED TO BE DISCHARGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Ischemia

  MAUDE report 15988472 ↗
• DeathNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, THE PATIENT DEVELOPED PNEUMOTHORAX, WHICH REQUIRED LONG TERM VENTILATION AND THORACOTOMIA WAS PERFORMED. THE CAUSE OF THE PNEUMOTHORAX WAS REPORTED AS UNKNOWN BUT THE PHYSICIAN ANTICIPATED TO BE A PROCEDURAL COMPLICATION. IT WAS ALSO NOTED THAT THE PATIENT HAD BACTERIAL PNEUMONIA DETECTED POSTOPERATIVELY AND WAS ON ANTIBIOTICS THERAPY. THE DEVICE IS WORKING AS INTENDED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Pneumonia; Pneumothorax

  MAUDE report 15854633 ↗
• InjuryNov 19, 2022Material Separation; Material Separation

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A 30MM RIGID RING SADDLE WAS SUCCESSFULLY IMPLANTED IN A PATIENT. ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL DUE TO SYMPTOMS OF DYSPNEA. AN ECHOCARDIOGRAM WAS PERFORMED AND DISCOVERED RING DEHISCENCE AND PRIMARY MITRAL VALVE REGURGITATION. THERE WAS NO SIGNS OF PROGRESSION OF THE DEHISCENCE. THE PATIENT WAS MONITORED AND GIVEN A REGIMEN OF HEART FAILURE MEDICATION. THE FOLLOW UP DETERMINE THAT THE PATIENT CURRENTLY DOES NOT REQUIRE SURGICAL INTERVENTION.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15830865 ↗
• MalfunctionOct 6, 2022Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT ON 15 SEPTEMBER 2022, A 30MM RIGID SADDLE RING WAS CHOSEN FOR IMPLANT. AFTER THE DEVICE WAS IMPLANTED, A WATER INJECTION TEST WAS PERFORMED AND SHOWED LIMITED FLAP MOVEMENT. THE DEVICE WAS THEN EXPLANTED AND REPLACED WITH ANOTHER 30MM RIGID SADDLE RING. THE PATIENT WAS REPORTED AS STABLE AND NORMAL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S MITRAL VALVE LEAFLETS WERE MOVING NORMALLY DURING TESTING. IT WAS ALSO NOTED THAT THE PATIENT'S VALVE COULD NOT CLOSE COMPLETELY. AFTER THE VALVE WAS EXPLANTED, THE USER TESTED THE LEAFLETS AND STATED THEY WERE MOVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15553206 ↗
• InjuryOct 5, 2022Lack of Effect; Lack of Effect

  N/A.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15546540 ↗
• InjuryAug 15, 2022Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT A 30MM RIGID SADDLE RING WAS IMPLANTED ON (B)(6) 2021, ON (B)(6) 2022 THE PATIENT HAD SEVERE MITRAL VALVE INSUFFICIENCY REQUIRING MITRAL VALVE REPLACEMENT. DURING PROCEDURE, PARENCHYMA DAMAGE LUNG REQUIRING DRAINS. POST PROCEDURE, PATIENT REQUIRED INOTROPIC FOR LONGER, BUT HAD NORMAL TENSIONS AND DIURESIS. ON (B)(6) 2022 FLUID OVERLOAD REQUIRING ORAL DIURETICS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15228276 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A TAILOR FLEXIBLE ANNULOPLASTY RING WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT EXPERIENCED WORSENING OF PRE-EXISTING ATRIAL FIBRILLATION FOUND ON ELECTROCARDIOGRAM (EKG). AMIODARONE AND BETA BLOCKERS WERE ADMINISTERED TO TREAT THE ARRHYTHMIA, AND A CARDIOVERSION WAS PERFORMED. THE ATRIAL FIBRILLATION WAS STILL PERSISTENT AT THE TIME OF DISCHARGE ON (B)(6) 2022. THERE WAS A PROLONGED HOSPITALIZATION DUE TO THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 14833750 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4), PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT EXPERIENCED MAJOR POST-OPERATIVE BLEEDING AND WAS RETURNED TO SURGERY. A BLOOD TRANSFUSION WAS PERFORMED. THE PATIENT WAS STABILIZED. ON (B)(6) 2022, THE PATIENT HAD SYMPTOMATIC BRADYCARDIA. ON (B)(6) 2022, A PERMANENT PACEMAKER WAS IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bradycardia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14598707 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A 30MM RIGID SADDLE RING WAS CHOSEN FOR PROCEDURE. AN ABBOTT RING SIZER SET WAS USED DURING THE PROCEDURE. THE MITRAL VALVE REPAIR INCLUDED A BILATERAL LEAFLET REPAIR AS WELL AS A CHORDAL REPLACEMENT WITH ARTIFICIAL CHORDAE OR SUTURE. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS NOTED. POST PROCEDURE, A PERICARDIAL EFFUSION WAS DISCOVERED, AND A DRAINAGE OF THE PERICARDIUM WAS THEN PERFORMED IN THE OPERATING ROOM. THE PATIENT WAS ALSO DIAGNOSED WITH SICK SINUS SYNDROME (SSS), AND A PERMANENT DUAL-CHAMBER PACEMAKER WAS IMPLANTED.

  Patient problems: Anemia; Arrhythmia; Atrial Fibrillation; Dyspnea; Mitral Valve Insufficiency/ Regurgitation; Nausea; Pericardial Effusion; Tachycardia; Vomiting

  MAUDE report 14517033 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6), CRD 985 ARB PMCF STUD, (B)(4). IT WAS REPORTED THAT ON (B)(6) 2022, A 30MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. CONCOMITANT CARDIAC PROCEDURES INCLUDED LEFT ATRIAL APPENDAGE CLOSURE, THORACIC AORTA REPAIR, AORTIC VALVE REPLACEMENT, AND CRYOABLATION. ON (B)(6) 2022, THE PATIENT WAS EVALUATED WITH AN ELECTROCARDIOGRAM (ECG) FOR 24 HOURS AND WAS NOTED TO HAVE A THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK. ON (B)(6) 2022, A PACEMAKER WAS IMPLANTED TO RESOLVE THIS EVENT, AND THE PATIENT WAS DISCHARGED. THE CAUSE OF THE AV BLOCK WAS UNKNOWN SINCE THERE WERE SEVERAL CONCOMITANT PROCEDURES PERFORMED. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Block

  MAUDE report 14251420 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 30MM SJM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH A RIGHT SIDED FLUIDTHORAX (PLEURAL EFFUSION) AND IT WAS REMOVED BY NEEDLE PUNCTURE. 500LM OF EFFUSION WAS SUCCESSFULLY EVACUATED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. (CRD_985 ARB PMCF; (B)(4)).

  Patient problems: Pleural Effusion

  MAUDE report 13515970 ↗
• InjuryJan 18, 2022Backflow; Backflow

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM RIGID SADDLE RING WAS IMPLANTED. AFTER PLACING THE RING, THERE WAS STILL TOO MUCH OF A LEAK AND IT WAS DECIDED TO DO A VALVE REPLACEMENT. THE PATIENT SUFFERED FROM MITRAL VALVE INSUFFICIENCY AND THE NATIVE VALVE WAS AFFECTED WITH RHEUMATIC FEVER. 27MM SJM MASTER SERIES MECHANICAL VALVE WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2021. NO LEAKAGE WAS NOTED AFTER THE MITRAL VALVE REPLACEMENT WAS PERFORMED. LATER, THE PATIENT EXPERIENCED DECREASE VISION IN THE RIGHT EYE. NO DIPLOPIA OR HEMIANOPIA WAS REPORTED AND CAUSE COULD NOT BE CONCLUDED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED TO THE REFERRING HOSPITAL ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS EXPERIENCING POST OPERATIVE ANEMIA AND WAS TRANSFUSED. THE PATIENT DOES NOT HAVE A HISTORY OF ANEMIA. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. ((B)(4)). RELATED MANUFACTURER REPORT NUMBER: 3007113487-2022-00021.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13285012 ↗
• InjuryAug 19, 2021Backflow; Backflow

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM RIGID SADDLE RING WAS SELECTED FOR IMPLANT. AFTER THE RING WAS IMPLANTED A LEAK/REGURGITATION WAS NOTED. THE RING WAS EXPLANT AND REPLACED WITH A 29MM EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM ON (B)(6) 2021. POST PROCEDURE NODAL RHYTHM WAS NOTED INTERSPERSED WITH BIGEMINY WAS NOTED AND NO MEDICAL INTERVENTION WAS PERFORMED. ON (B)(6) 2021, PERIPHERAL EDEMA WAS REPORTED AND MEDICATION WAS ADMINISTRATED. ON (B)(6) 2021, PLEURAL FLUID AND A PERICARDIAL EFFUSION WAS NOTED POST SURGERY AND DIURETICS WERE GIVEN AND AN ACUTE PERICARDIOCENTESIS WAS PERFORMED. LOW HEMOGLOBIN WAS NOTED AND IT WAS DUE TO A TAMPONADE AND THE PATIENT RECEIVED VITAMIN K AND COFACT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND IS RECOVERING. ADDITIONAL INFORMATION IS PENDING. ((B)(4)).

  Patient problems: Arrhythmia; Cardiac Tamponade; Pericardial Effusion; Swelling/ Edema

  MAUDE report 12341337 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 30MM SJM RIGID SADDLE RING WAS IMPLANTED. POST PROCEDURES AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND LOWER WALL ISCHEMIA WAS NOTED. A CORONARY ANGIOGRAM PROCEDURE (CAG) WAS PERFORMED. THE LOWER WALL ISCHEMIA IS THOUGHT TO BE DUE TO THE PROCEDURE. ON (B)(6) 2021, ATRIAL FIBRILLATION AND FLUID OVERLOAD WAS NOTED DUE TO THE PROCEDURE. ON (B)(6) 2021, A PACEMAKER WAS IMPLANTED AND IV MEDICATIONS WERE ADMINISTRATED. THE PATIENT IS STILL EXPERIENCING DYSPNEA, TIREDNESS, NAUSEA AND SEPTUM PAIN. THE PATIENT IS RECOVERING. THE PATIENT HAS A HISTORY OF HYPERTENSION. ADDITIONAL INFORMATION IS PENDING. (CRD_985 - ARB PMCF, EU1671-303; R618952601, R618146801, R618146501, R617859901, R618146801).

  Patient problems: Anemia; Atrial Fibrillation; Dyspnea; Fatigue; Implant Pain; Ischemic Heart Disease; Nausea; Pericardial Effusion

  MAUDE report 12293051 ↗