ALTRUA™ 60 S606Recalls & reported problems

Summary

The FDA's MAUDE database contains 649 adverse event reports that list this exact device (DI 00802526484490), received between Apr 21, 2016 and Sep 4, 2026 — classified as 3 deaths, 446 injuries, 200 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (149 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 649 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this pacemaker was explanted and replaced with a non-Boston Scientific device. No further information was available. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602088 ↗
• InjuryAug 21, 2026Interrogation Problem

  It was reported that this pacemaker was unable to be interrogated. Technical Services (TS) was consulted and noted that the device had indicated approximately two years of remaining longevity in 2022. Based on the available information, TS suspected that the device had reached Battery Capacity Depleted (BCD) status. This device remains in service. No adverse patient effects were reported.Additional information was received from the field stating this patient experienced syncope and a device replacement was performed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 50376476 ↗
• MalfunctionAug 19, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329744 ↗
• MalfunctionJun 11, 2026Over-Sensing; Data Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED FAR FIELD OVERSENSING ON THE ATRIAL CHANNEL. ADDITIONALLY, TECHNICAL SERVICES (TS) NOTED THAT RIGHT VENTRICULAR (RV) CHANNEL MARKERS WERE NOT VISIBLE ON THE PRESENTING ELECTROGRAM (EGM). NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479993 ↗
• MalfunctionMay 21, 2026High impedance

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS FOR ITS RIGHT ATRIAL (RA) LEAD DURING ITS SCHEDULED EXPLANT PROCEDURE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED TROUBLESHOOTING OPTIONS TO TEST THE RA LEAD AND ENSURE ITS INTEGRITY. THIS PACEMAKER WAS EXPLANTED AND REPLACED AS SCHEDULED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THE RA LEAD WAS PROGRAMMED TO ITS UNIPOLAR PACING VECTOR, WITH THE MEASUREMENTS WITHIN RANGE FOR THIS SETTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243986 ↗
• InjuryMay 8, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES IN THE RIGHT ATRIAL (RA) CHANNEL. THE PATIENT WAS NOTED TO HAVE TWO RA LEADS, WITH ONE CONNECTED TO THE RIGHT VENTRICULAR (RV) PORT OF THE DEVICE; HOWEVER, THE HEALTH CARE PROFESSIONAL (HCP) DID NOT CLARIFY WHICH RA LEAD WAS CONNECTED TO THE RV PORT. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPLACEMENT IN THE NEAR FUTURE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THIS ICD WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. OTHER THAN THE INTERVENTION, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129114 ↗
• MalfunctionMay 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO UPLOAD DEVICE DATA. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS. IT WAS SUSPECTED THAT THIS DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) SINCE IT WAS IMPLANTED IN 2011. TS RECOMMENDED FURTHER REVIEW WITH A PROGRAMMER. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073402 ↗
• InjuryMar 31, 2026Premature Discharge of Battery; Battery Problem; Data Problem

  IT WAS REPORTED THAT THIS PACEMAKER DELIVERED 11 ATRIAL TACHY RESPONSE (ATR) EPISODES BUT ONLY TWO WERE RECORDED ON THE LOGBOOK. IN ADDITION, IT WAS MENTIONED THAT OVER THE LAST MONTHS THE BATTERY LONGEVITY TIME HAS DECREASED FROM TWO YEARS TO LESS THAN SIX MONTHS REMAINING. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON DATA REVIEW DISCUSSED WITH THE HEALTH CARE PROFESSIONAL (HCP) THE POSSIBILITY THAT THE WRONG TIME AND DATE SETTINGS WERE SELECTED DURING THE RESYNCHRONIZATION OF THE DEVICE. TS INSTRUCTED THE HCP TO RESTART THE LOGBOOK AND RECOMMENDED NORMAL DEVICE FOLLOW UP AND MONITORING. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, TS DISCUSSED THAT THE DEVICE HAS EXCEEDED LONGEVITY EXPECTATION. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE AND HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE CONCLUSION CODE UNABLE TO EXCLUDE DEVICE PROBLEM WAS ASSIGNED. ADDITIONAL INFORMATION WAS RECEIVED; THIS PACEMAKER WAS EXPLANTED AND REPLACED AND H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747659 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24613974 ↗
• InjuryFeb 25, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WENT INTO ATRIAL FIBRILLATION (AF) DUE TO NOISE SIGNALS. THE FIRST AF EVENT OCCURRED AFTER USING ELECTROCAUTERY. CARDIOVERSION WAS UTILIZED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: Atrial Fibrillation

  MAUDE report 24448953 ↗
• InjuryJan 14, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER COMPLAINED OF SHORTNESS OF BREATH (SOB) AND INABILITY TO INCREASE THEIR HEART RATE ABOVE 50 BEATS PER MINUTE (BPM). INTERROGATION OF THE DEVICE WITH A PROGRAMMER IN CLINIC FOUND THE DEVICE TO BE AT END OF LIFE (EOL) AT VVI 50. A HEALTH CARE PROFESSIONAL (HCP) QUESTIONED IF THE DEVICE DEPLETED EARLY, HOWEVER, IT WAS DIFFICULT TO DETERMINE ACCURATE LONGEVITY FROM THE PREVIOUS IN CLINIC VISIT BASED ON THE AVAILABLE DEVICE INFORMATION. THE DEVICE WAS NOTED TO HAVE BEEN IMPLANTED FOR APPROXIMATELY 14 YEARS. SURGICAL INTERVENTION WAS UNDERTAKEN. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

  Patient problems: Dyspnea

  MAUDE report 24075498 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. AT THIS TIME, THIS PACEMAKER HAS NOT BEEN RETURNED FOR ANALYSIS, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23948643 ↗
• InjuryDec 8, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAS DEPLETED FROM 3 YEARS TO REACHING END OF LIFE (EOL) AS PER CURRENT CHECKED IN A SPAN OF 7 MONTHS. THIS PACEMAKER WAS EXPLANTED, REPLACED WITH DIFFERENT MODEL AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742197 ↗
• InjuryNov 21, 2025Premature Discharge of Battery; Interrogation Problem; Premature Discharge of Battery; Interrogation Problem

  IT WAS REPORTED THAT DURING AN IN-OFFICE VISIT THERE WAS DIFFICULTY INTERROGATING THIS PACEMAKER. MAGNET RESPONSE WAS FOUND, BUT THERE WAS CONCERNS OF PREMATURE BATTERY DEPLETION. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618849 ↗
• InjuryJul 18, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD A YEAR LEFT AND WAS COMPLETE OUT OF SERVICE A MONTH BEFORE THE EXPLANT DATE. THIS PACEMAKER WAS EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THIS PACEMAKER WAS EXPLANTED DUE TO ELECTIVE REPLACEMENT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543789 ↗
• MalfunctionJun 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED LONGEVITY CALCULATIONS FROM 2.5 YEARS TO ELECTIVE REPLACEMENT TIME (ERT) IN A SPAN OF 4 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SCHEDULED PATIENT FOR REPLACEMENT. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335626 ↗
• MalfunctionJun 26, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER LONGEVITY DROPPED FROM 3.5 YEARS TO END OF LIFE (EOL) IN A SPAN OF 14 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE LIKELY REASON FOR THE DEVICE TO HAVE UNEXPECTEDLY REACHED EOL IS DUE TO CURRENT BIN CHANGE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334159 ↗
• InjuryJun 13, 2025Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22206883 ↗
• InjuryJun 12, 2025Failure to Capture; Pacing Problem; Data Problem; Failure to Capture; Pacing Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER EXPERIENCED CARDIAC ARREST. UPON REVIEW, IT WAS NOTED THAT THE DEVICE IS PROGRAMMED IN AOO MODE, AN UNUSUAL PERMANENT SETTING, RAISING CONCERNS ABOUT POTENTIAL LEAD ISSUES. DURING PROGRAMMER TESTING, 100% RV PACING WAS OBSERVED, LIKELY DUE TO TESTING CONDITIONS, AS RV PACING SHOULD NOT OCCUR IN AOO MODE. IN ADDITION, RA LOSS OF CAPTURE WAS SUSPECTED AS A RESULT OF THE PROGRAMMING. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 22199400 ↗
• MalfunctionMay 16, 2025Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED INTERROGATION DIFFICULTIES. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT THE DEVICE HAS BEEN IMPLANTED FOR OVER 10 YEARS, AND THE BATTERY STATUS WAS UNKNOWN. TS DETERMINED THAT THE DEVICE BATTERY WAS LIKELY TOO DEPLETED TO ESTABLISH COMMUNICATION. HOWEVER, THE FIELD REPRESENTATIVE INDICATED THAT THIS WAS UNLIKELY, AS THE DEVICE WAS PROJECTED TO HAVE APPROXIMATELY TWO YEARS OF SERVICE LIFE REMAINING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036628 ↗
• InjuryApr 4, 2025Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER HAD A CARDIOVERSION. SUBSEQUENTLY, ATRIAL AND VENTRICULAR PACING WAS NOTED ON THE PROGRAMMER; HOWEVER, THE PATIENT WAS IN ASYSTOLE, THEREFORE, THE CLINICAL REPRESENTATIVE SUGGESTED A POSSIBLE LOSS OF CAPTURE (LOC). AS A RESULT, THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS. ADDITIONAL INFORMATION INDICATED THAT DURING THE PREVIOUSLY MENTIONED INTERROGATION, IT WAS OBSERVED THAT DEVICE HAD A LOW BATTERY DUE TO NORMAL BATTERY DEPLETION. THE CLINICAL REPRESENTATIVE SUSPECTED THAT THE INTERROGATION CAUSED A DROP IN THE REMAINING BATTERY, LEADING TO PACING INHIBITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS.

  Patient problems: Asystole

  MAUDE report 21777944 ↗
• InjuryApr 3, 2025Pacing Problem; Inaccurate Synchronization; Pacing Problem; Inaccurate Synchronization

  IT WAS REPORTED THAT THIS PACEMAKER WAS IN END OF LIFE (EOL) AND PROVIDED INAPPROPRIATE PACING ON A T-WAVE. AS A RESULT, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF). AN EXTERNAL SHOCK WAS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER ANALYSIS.

  Patient problems: Ventricular Fibrillation

  MAUDE report 21762966 ↗
• MalfunctionApr 1, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW OF THIS PACEMAKER SYSTEM REVEALED FARFIELD R-WAVE OR T-WAVE OVERSENSING, RESULTING IN A SHORT ATRIAL TACHY RESPONSE (ATR) EPISODE BEING RECORDED. NO OUT OF RANGE MEASUREMENTS WERE NOTED. THIS PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746806 ↗
• MalfunctionMar 31, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER HAS DEPLETED FROM 2 YEARS BATTERY REMAINING AND DURING THE RECENT CHECK, THIS PACEMAKER HAS REACHED ELECTIVE REPLACEMENT INDICATOR IN A SPAN OF 1 MONTH. THERE WAS NO PROGRAMMING CHANGES WERE MADE, HOWEVER, NOTED RIGHT VENTRICULAR AUTOMATIC CAPTURE AT HIGHER OUTPUT. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED HOW THIS DEVICE MANAGES THE BATTERY, AND THIS IS NOT LIKELY A PREMATURE BATTERY DEPLETION AS IT IS A PRODUCT OF THE BATTERY MANAGEMENT ALGORITHM DESIGN. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728823 ↗
• MalfunctionMar 20, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT A LEAD SAFETY SWITCH (LSS) WAS ACTIVATED IN RIGHT VENTRICULAR (RV) LEAD OF THIS PACEMAKER SYSTEM, SWITCHING FROM BIPOLAR TO UNIPOLAR MODE DUE TO AN UNSPECIFIED OUT OF RANGE IMPEDANCE MEASUREMENT. TECHNICAL SERVICES (TS) EXPLAINED DETAILS ABOUT THE LSS AND RECOMMENDED FURTHER RV LEAD EVALUATION. TS ALSO PROVIDED PROGRAMMING OPTIONS. THE RV LEAD IS A NON-BOSTON SCIENTIFIC DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652596 ↗