ALTRUA™ 40 S403Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00802526484445), received between May 1, 2016 and Jun 3, 2022 — classified as 1 death, 20 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A FAULT CODE MESSAGE DISPLAYED ON THE PROGRAMMER WHILE INTERROGATING THE PACEMAKER. THE PATIENT EXPERIENCED A VERY BRIEF PRE-SYNCOPE DURING THE SESSION. THE DEVICE HAS BEEN EXPLANTED AND A NEW DEVICE IMPLANTED AT THE SAME SURGICAL INTERVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Presyncope

  MAUDE report 14594425 ↗
• MalfunctionMay 9, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DECLARED END OF LIFE AND WAS SUBSEQUENTLY SCHEDULED FOR REPLACEMENT. THE DEVICE SHOWED NORMAL BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341993 ↗
• MalfunctionNov 2, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING DEVICE CHECK AND THRESHOLD TEST WAS PERFORMED THE BATTERY SHOWED ONE YEAR REMAINING, HOWEVER, WHEN UPLOADED INTO PACEART VIA UNIVERSAL SERIAL BUS (USB) THE DEVCIE DATA STATED ELECTIVE REPLACEMENT INDICATOR (ERI). PATIENT WAS BROUGHT BACK IN THE CLINIC AND IT SHOWED LESS THAN HALF A YEAR BUT THEN WHEN LOADED AGAIN IN PACEART IT SHOWED ERI. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE GAS GAUGE IS VERY CLOSE TO ERI, BUT NOT IN THE YELLOW YET AND THERE IS NO ERI DATE STAMP AVAILABLE. THE DEVICE BATTERY WAS OKAY WITH MAGNET RATE AT NINETY INDICATING ELECTIVE REPLACEMENT NEAR. TS ADVISED CONTINUE MONITORING MAGNET RATE FOR ERI AS IT IS A BETTER INDICATOR OF ERI. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741933 ↗
• MalfunctionNov 2, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER COULD NOT BE RECOGNIZED BY A CONSULT COMMUNICATOR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS DEVICE DID NOT LAST FOR 12 YEARS. THUS, WONDERING IF THE DEVICE WAS EITHER CHANGED OUT OR NON-FUNCTIONAL. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735933 ↗
• MalfunctionJul 8, 2021Premature Discharge of Battery; Telemetry Discrepancy; Battery Problem; Interrogation Problem; Premature Discharge of Battery; Telemetry Discrepancy; Battery Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXPERIENCED DIFFICULTY BEING INTERROGATED. TECHNICAL SERVICES (TS) WALKED THE HEALTH CARE PROFESSIONAL THROUGH TROUBLESHOOTING INCLUDING THE USE OF A MAGNET AND A DIFFERENT PROGRAMMER WAND. IT WAS DISCOVERED THE DEVICE WAS AT END OF LIFE. TS DISCUSSED THAT TELEMETRY PLACED A LARGE STRAIN ON THE BATTERY OF THE DEVICE WHICH RESULTED IN DIFFICULTY INTERROGATING THE DEVICE AND RECOMMENDED DEVICE REPLACEMENT. IT WAS NOTED THAT THE PATIENT WAS NOT PACEMAKER DEPENDENT AT THAT TIME. THE DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139518 ↗
• MalfunctionMay 3, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT PACEMAKER HAD REACHED ELECTIVE REPLACEMENT TIME (ERT) STATUS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED REPLACING THE DEVICE. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11767387 ↗
• InjuryDec 18, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR THIS DUAL CHAMBER PACEMAKER. IT IS UNKNOWN IF THE EXPLANTED DEVICE WAS REPLACED. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS REPORT IS BEING FILLED AS DEVICE EVALUATION WAS COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 11042385 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10255161 ↗
• InjuryJan 3, 2020Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD ERODED THROUGH THE SKIN. INTERVENTION WAS SCHEDULED. ON THE DAY OF INTERVENTION THE DEVICE COULD NOT BE INTERROGATED. THERE WERE NO ALLEGATIONS OF PREMATURE BATTERY DEPLETION (PBD) AND IT WAS REPORTED THAT THE DEVICE EXHIBITED NORMAL DEPLETION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9546936 ↗
• InjuryJul 31, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO BATTERY DEPLETION AND DEVICE MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848441 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE DEVICE EVALUATION RESULTS.

  Patient problems: Dizziness; Syncope

  MAUDE report 8758555 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PREVIOUSLY THIS PACEMAKER SHOWED ONE YEAR REMAINING LONGEVITY. AFTER 5 MONTHS, THE DEVICE SHOWED LESS THAN SIX MONTHS REMAINING LONGEVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) OFFERED TO REVIEW MEMORY DUMP AND SAVE TO DISKETTE IF DESIRED. THE PATIENT WILL BE SEEN AGAIN IN THREE MONTHS. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD WHICH INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8597557 ↗
• MalfunctionApr 24, 2019High impedance; Over-Sensing; Device Sensing Problem; High impedance; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THIS PACEMAKER AND COMPETITOR RIGHT ATRIAL (RA) LEAD EXHIBITED EPISODES OF NOISE AND OVERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA NOTING EVIDENCE OF AN AUTOMATIC LEAD CONFIGURATION SWITCH HAD OCCURRED RELATED TO OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS. HIGH FREQUENCY NOISE CONSISTENT WITH AN EXTERNAL INTERFERENCE OR MINUTE MENTILLATION (MV) SENSOR OVERSENSING WAS CONFIRMED. TS PROVIDED SUGGESTIONS FOR ADDITIONAL SYSTEM EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546591 ↗
• InjuryFeb 8, 2019Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS NOTED THAT THIS PACEMAKER BATTERY WAS DRAINING AND HAD ONE YEAR LEFT. MOREOVER, THE PHYSICIAN OPTED TO REPLACE THE DEVICE. AN ATTEMPT TO OBTAIN ADDITIONAL PERTINENT INFORMATION WAS UNSUCCESSFUL. THIS PACEMAKER WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324107 ↗
• InjuryFeb 8, 2019Premature Discharge of Battery; Defective Device; Premature Discharge of Battery; Defective Device

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8324096 ↗
• InjuryJan 28, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS SUSPICION THAT THIS PACEMAKER'S BATTERY WAS DEPLETING PREMATURELY. REPORTEDLY, A DEVICE INTERROGATION IN AUGUST SHOWED 1.5 YEARS OF BATTERY REMAINING, BUT THE DEVICE REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) THREE MONTHS LATER. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283302 ↗
• InjuryJan 23, 2019Premature Discharge of Battery; High Capture Threshold; Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP THIS PACEMAKER WAS FOUND TO HAVE TRIGGERED A REPLACEMENT INDICATOR. IT WAS NOTED THAT THE PATIENT HAD NEAR 100% RIGHT ATRIAL (RA) LEAD PACING AND APPROXIMATELY 40% RIGHT VENTRICULAR (RV) LEAD PACING SINCE IMPLANT. MAGNET RATES CORRESPONDING TO DEPLETION LEVEL WERE FOUND INCONSISTENT IN THE MONTHS PRECEDING A REQUEST BY THE PHYSICIAN FOR DEVICE DATA ANALYSIS DUE TO SUSPECTED PREMATURE DEPLETION. ENGINEERING ANALYSIS FOUND THE DEVICE WAS OPERATING NEAR A DEPLETION INDICATOR BOUNDARY THAT MAY HAVE EXPLAINED THE OBSERVED BEHAVIOR. INFORMATION WAS LATER RECEIVED INDICATING A REVISION PROCEDURE WAS PERFORMED AT WHICH TIME THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271284 ↗
• DeathDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BOSTON SCIENTIFIC RECEIVED INFORMATION ON NOVEMBER 12, 2018 FROM A FAMILY MEMBER. THE PATIENT WAS IMPLANTED WITH A BOSTON SCIENTIFIC ALTRUA 40 MODEL S430 PACEMAKER ON (B)(6) 2011. ACCORDING TO THE FAMILY MEMBER, THE PATIENT SUFFERED A STROKE THE FOLLOWING DAY WHICH CAUSED A NUMBER OF POST-STROKE COMPLICATIONS. THE PATIENT DIED ON (B)(6) 2012.

  Patient problems: Death; Stroke/CVA

  MAUDE report 8153210 ↗
• InjuryOct 25, 2018Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS OVERSENSING ATRIAL ACTIVITY ON THE VENTRICULAR CHANNEL RESULTING IN PACING INHIBITION FOR A DEPENDENT PATIENT. AS A RESULT OF THE PACING INHIBITION THE PATIENT BECAME SYNCOPAL. THE BLANKING PERIOD AFTER ATRIAL ACTIVITY WAS EXTENDED BUT DID NOT RESOLVE THE ISSUE. THE VENTRICULAR SENSITIVITY WAS MODIFIED TO MAXIMUM SENSITIVITY WHICH IMPROVED THE OVERSENSING BUT DID NOT ELIMINATE IT. THE PHYSICIAN REPORTED THAT THERE WERE NO PROBLEMS WITH LEAD PLACEMENT BASED ON X-RAY IMAGING. THE PATIENT WAS MONITORED OVERNIGHT IN THE HOSPITAL AND DISCHARGED THE FOLLOWING DAY. NO SURGICAL INTERVENTION WAS PERFORMED AND THE DEVICE REMAINS IN SERVICE.

  Patient problems: Syncope

  MAUDE report 8006315 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO STAPHYLOCOCCUS INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Staphylococcus Aureus; Unspecified Infection

  MAUDE report 7622488 ↗
• InjuryApr 9, 2018Over-Sensing; Pacing Problem; Failure to Sense; Low impedance; Ambient Noise Problem; Capturing Problem; Over-Sensing; Pacing Problem; Failure to Sense; Low impedance; Ambient Noise Problem; Capturing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WERE THREE OR MORE EPISODES OF ASYSTOLE DUE TO OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE RV LEAD ALSO EXHIBITED INCREASED THRESHOLD MEASUREMENTS AND NON DETECTION OF SENSING. AGGRESSIVE MANIPULATION OF POCKET WAS UNABLE TO REPRODUCE ANY NOISE OR OVERSENSING. OUTPUTS AND SENSITIVITY WERE REPROGRAMMED AND THE PATIENT WAS HOSPITALIZED FOR A REVISION PROCEDURE. THE PACEMAKER WAS INTERROGATED THE FOLLOWING DAY WITH PROGRAMMING SHOWING THE DEVICE TO BE PACING AND SENSING IN THE VENTRICLE ONLY, HOWEVER PAUSES IN PACING WERE STILL OBSERVED THUS A TEMPORARY PACING WIRE WAS PLACED. IT WAS ALSO NOTED THAT THE RV IMPEDANCE MEASUREMENTS WERE AT 400 OHMS CURRENTLY BUT WAS 1190 AT IMPLANT. A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED AND THE PACEMAKER WAS EXPLANTED. A NEW DEVICE AND LEAD WERE SUCCESSFULLY IMPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7407906 ↗
• InjuryJan 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED FOR REPORTED NORMAL BATTERY DEPLETION APPROXIMATELY TWO MONTHS LATER.

  Patient problems: Syncope

  MAUDE report 7195469 ↗
• InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO BACTERIAL INFECTION WITH SEPSIS. THE PATIENT WAS ALSO NOTED WITH BRADYCARDIA, DIZZINESS AND FAINTING SPELLS, NON-ISCHEMIC DILATED CARDIOMYOPATHY, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (ASCVD), HYPERTENSION, ENDOCARDITIS AND (B)(6). THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Atherosclerosis; Bacterial Infection; Bradycardia; Cardiomyopathy; Dizziness; Endocarditis; Fainting; High Blood Pressure/ Hypertension; Sepsis; Staphylococcus Aureus

  MAUDE report 6938015 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WITH THIS PACEMAKER EXPERIENCED PAIN ON THE DEVICE'S POCKET. THE PHYSICIAN OPTED TO REVISE THE POCKET. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 6718712 ↗
• InjuryJul 22, 2016High impedance; High impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH PACING IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. A REQUEST FOR ADDITIONAL INFORMATION AND RETURN OF THE DEVICE WAS MADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5816220 ↗