ALTRUA™ 60 S603Recalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00802526484483), received between Apr 22, 2016 and Aug 10, 2026 — classified as 4 deaths, 197 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (48 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 272 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Interrogation Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) for a consult interrogation of this pacemaker system. Troubleshooting efforts were not attempted due to patient left against medical advise. No adverse patient effects were reported. At this time, this pacemaker remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197050 ↗
• InjuryApr 14, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS ORIGINALLY IMPLANTED BACKWARD. THE FOLLOWING DAY, A REOPERATION WAS PERFORMED AND HAD TO RELOCATE THE DEVICE ON THE PATIENT'S BODY. ON THE NEXT DAY, THE PATIENT UNDERGONE ANOTHER SURGERY ON THE NECK PART DUE TO PLAQUE ACCUMULATION. SUBSEQUENTLY, THIS PACEMAKER WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AND REPLACED WITH DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876102 ↗
• MalfunctionMar 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) INQUIRED ABOUT THE HYPERBARIC OXYGEN THERAPY (HBOT) RATING OF THIS PACEMAKER. TECHNICAL SERVICES (TS) ASSESSED AND INDICATED THAT THE DEVICE MODEL IN QUESTION WAS RATED FOR USE UP TO 5.0 ATMOSPHERES ABSOLUTE (ATA) WHEN FUNCTIONAL. THE HCP INDICATED THAT THE PATIENT STATED THE DEVICE WAS NO LONGER FUNCTIONAL; HOWEVER, DEVICE EXPLANTATION WAS CONSIDERED TOO HIGH RISK. TO DATE, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608338 ↗
• MalfunctionOct 31, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING OF AN ARTIFACT ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL OF THIS PACEMAKER SYSTEM. THIS RESULTED IN A STORED VENTRICULAR EPISODE. TECHNICAL SERVICES (TS) ANALYZED DEVICE EPISODE DATA AND THE PRESENTING ELECTROGRAM (EGM) AND RECOMMENDED REPROGRAMMING THE SENSITIVITY AS TROUBLESHOOTING. THE DEFLECTION WAS NOT REPRODUCED BY ISOMETRIC ARM MOVEMENTS IN CLINIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039929 ↗
• MalfunctionSep 12, 2023Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW OF THIS PACEMAKER REVEALED ATRIAL UNDERSENSING AND INAPPROPRIATE ATRIAL PACING WHILE IN FALLBACK MODE AND DDI. ATRIAL SENSITIVITY WAS REPROGRAMMED. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733890 ↗
• InjuryMay 10, 2023Adverse 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 POCKET EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE PACEMAKER REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16901756 ↗
• InjuryOct 11, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER BATTERY WAS AT LESS THAN HALF A YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO LOOK BACK TO SEE IF HEALTH CARE PROFESSIONAL (HCP) CAN DETERMINE WHEN THE FIRST THE MAGNET RATE WAS NOTED AND WILL BE ABOUT ONE YEAR FROM THAT TIME FRAME THAT DEVICE WILL REACH ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581336 ↗
• InjurySep 13, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION (PBD). A NEW NON-BSC DEVICE WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410290 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WITH A PACEMAKER DEVICE PASSED OUT WHEN A THRESHOLD TEST WAS PERFORMED DURING A DEVICE CHECK. THE INCIDENT WAS NOTED TO HAVE HAPPENED A YEAR AGO. THE DEVICE REMAINS IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 15363242 ↗
• MalfunctionJul 13, 2022Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING A BATTERY REPLACEMENT PROCEDURE, NOISE WITH OVERSENSING WAS OBSERVED WITH ELECTROCAUTERY USE AND IT WAS NOTED THAT "THE PULSE SEEMS TO HAVE EXTENDED". IT WAS NOTED THAT THE PATIENT HAD AN INTRINSIC HEART RATE OF 50 BPM AND THE DEVICE WAS PROGRAMMED TO VVI 40. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THERE WAS PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE AS WELL AS PACING DELIVERED WHEN NOT REQUIRED. THE OBSERVED BEHAVIOR STOPPED WHEN ELECTROCAUTERY WAS STOPPED. THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Asystole

  MAUDE report 15003803 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO THE DEVICE REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PATIENT EXPERIENCING A SYNCOPE EPISODE. ANOTHER DEVICE WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 14582726 ↗
• MalfunctionJun 1, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER IS NO LONGER ACTIVE. THE DEVICE HAS BEEN CHECKED BY A PHYSICIAN AND THE PATIENT WAS INFORMED THAT IT NEVER WORKED AND THE DEVICE BATTERY IS GOING DEAD. THE DEVICE REMAINS IMPLANTED AS PLACING THE PATIENT TO SLEEP DURING SURGERY IS NO LONGER ADVISABLE FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570389 ↗
• MalfunctionApr 26, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THIS PACEMAKER'S LONGEVITY WAS LESS THAN SIX MONTHS AND THE PHYSICIAN WAS VERY FRUSTRATED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212205 ↗
• InjuryApr 26, 2022Adverse 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. REPORTEDLY, THE PATIENT HAD METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 14212201 ↗
• InjuryFeb 5, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE SHOWED HALF A YEAR REMAINING FROM TWO MONTHS AGO WITH MAGNET RATE OF NINETY. RECENTLY, DEVICE BATTERY WAS AT ONE YEAR REMAINING WITH THE SAME MAGNET RATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED BATTERY PERFORMANCE WOULD VARY A LOT IN THIS DEVICE IN WHICH IT COULD BE THAT THE LOW ESTIMATE WAS RIGHT AFTER A TELEMETRY SESSION THAT TOOK LONGER OR LEAD TESTING. TS THEN ADVISED TO SAVE TO DISK FOR ANALYSIS. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13466914 ↗
• InjuryFeb 4, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PACEMAKER DEVICE HAS BEEN STUCK AT LESS THAN SIX MONTHS OF REMAINING BATTERY FOR OVER A YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED LIKELY OPERATING ABOVE AND BELOW A GIVEN CURRENT BIN. TS THEN ADVISED CAN DO A FULL SAVE TO DISK FOR ENGINEERING INTERPRETATION AND POSSIBLE REMAINING LONGEVITY. FURTHER, THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13462353 ↗
• InjuryFeb 4, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT STATED THAT THIS PACEMAKER WAS DEFECTIVE. IN ADDITION, AS PER MEDICAL FORM IT WAS STATED THAT THE DEVICE WAS EXPLANTED DUE TO PATIENT CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13461835 ↗
• InjuryJan 22, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT AT A REGULAR FOLLOW-UP APPOINTMENT, IT WAS NOTED THAT THIS DEVICE BATTERY LONGEVITY HAD DECREASED FROM TWO YEARS REMAINING TO LESS THAN SIX MONTHS. THE PHYSICIAN SUSPECTED THAT THIS BATTERY WAS PREMATURELY DEPLETING. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS INDICATED THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13326953 ↗
• InjuryOct 19, 2021Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT DURING A RECENT FOLLOW-UP VISIT TO CHECK THE BATTERY STATUS OF THIS DEVICE, END OF LIFE (EOL) WAS REACHED. APPROXIMATELY 3 MONTHS PRIOR, THE BATTERY LONGEVITY SHOWED UNDER 6 MONTHS REMAINING. IT WAS NOTED THAT THERE HAD BEEN NO PROGRAMMING CHANGES WERE MADE BETWEEN THE MOST RECENT FOLLOW-UP VISITS. IT WAS ALSO NOTED THAT EARLIER THIS YEAR, THE BATTERY SHOWED LESS THAN 0.5 YEARS REMAINING, WITH A MAGNET RATE OF 90 PULSES PER MINUTE (PPM). TECHNICAL SERVICES EXPLAINED DEVICE BEHAVIOR, AND DISCUSSED THAT IT WILL GO TO 90 PPM ABOUT A YEAR PRIOR TO DECLARING ELECTIVE REPLACEMENT TIME (ERI). FROM ERI TO EOL, THERE IS A 90 DAY TIMER, SO THE DEVICE MOST LIKELY DECLARED ERI SHORTLY HAVE THE DEVICE WAS INTERROGATED A FEW MONTHS PRIOR. THE HEALTH CARE PROVIDED STATED THAT THE PATIENT IS NOT PACER DEPENDENT. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. THIS DEVICE HAD BEEN IMPLANTED FOR NEARLY 12 YEARS, HAVING EXCEEDED THE PROJECTED LONGEVITY EXPECTATIONS. A GOOD FAITH EFFORT WILL BE SUBMITTED TO THE FIELD TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661449 ↗
• InjuryOct 12, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT WHILE PERFORMING A DEVICE CHECK, THIS PACEMAKER WAS UNABLE TO PERFORM THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE TEST. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED TROUBLESHOOTING OPTIONS. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR WHEN ANALYSIS IS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12618712 ↗
• InjuryAug 3, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER DEVICE HAS MALFUNCTIONED. THE HEALTH CARE PROVIDER (HCP) REQUESTED FOR A BOSTON SCIENTIFIC REPRESENTATIVE TO CHECK THE DEVICE. ADDITIONALLY, THE DEVICE WAS ALREADY EXPLANTED AND REPLACED WITH A NEW ONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271711 ↗
• MalfunctionJul 29, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER DEVICE HAD LESS THAN SIX MONTHS REMAINING BATTERY UPON INTERROGATION LAST DECEMBER. HOWEVER, WHEN CHECKED IN APRIL DEVICE SHOWED ONE YEAR REMAINING BATTERY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED GAS GAUGE BEHAVIOR, POSSIBLE REASONS AND WAS REFERRED TO THE PHYSICIAN FOR FURTHER DISCUSSION OF CHANGED IN PROGRAMMED PARAMETERS. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250543 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER EXHIBITED INFECTION. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE PACEMAKER REMAINS IN SERVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 12243329 ↗
• InjuryJul 23, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PACEMAKER JUST WENT INTO END OF LIFE (EOL) STATUS FROM FIVE MONTHS ABOVE ELECTIVE REPLACEMENT TIME (ERT) SEVERAL MONTHS BACK. THE DEVICE WAS EXPLANTED AND WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12221341 ↗
• InjuryJul 23, 2021Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED BATTERY DEPLETION. MOREOVER, THE PATIENT EXPERIENCED POCKET DISCOMFORT AND THEREFORE REQUIRED A POCKET REVISION. THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 12218378 ↗