ALTRUA™ 60 S601Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00802526484469), received between May 1, 2016 and Jul 11, 2023 — classified as 83 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (33 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 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR AND HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED. THIS PACEMAKER PREVIOUSLY SHOWED 2 YEARS IN THE ESTIMATED REMAINING BATTERY LONGEVITY; HOWEVER, LATER DECLARED END OF LIFE (EOL). MAGNET APPLICATION SHOWED A MAGNET RATE OF 86 BEATS PER MINUTE, AND THE DEVICE STILL APPEARED TO HAVE ESCAPE INTERVAL OF 1200MS. TECHNICAL SERVICES (TS) WERE CONSULTED AND DISCUSSED THAT THE INITIAL OBSERVATIONS SHOWED THAT THE RV OUTPUT WAS SET TO AUTO 5.0V. A TS CONSULTANT DISCUSSED THAT IN ORDER TO GET TO AUTO 5V, THE DEVICE WOULD HAVE BEEN IN SUSPENSION. ALTRUA DEVICES, ERI ADJUSTS OUTPUTS IN THE DEVICE TO A MINIMUM OF 3.5V. WITH AUTOMATIC CAPTURE ON, IF THE DEVICE WENT INTO RETRY MODE, THAT WILL PULL ERI FORWARD AS THE DEVICE HAS TO ACCOUNT FOR HIGH OUTPUT PACING FOR THE 90-DAY PERIOD BETWEEN ERI AND EOL. IN THIS CASE, ERI WOULD HAVE BEEN SET IN APRIL, AND 90 DAYS LATER THE DEVICE DECLARED EOL. AT THE TIME OF THE FOLLOW-UP IN (B)(6) 2021, THE DEVICE WOULD HAVE BEEN IMPLANTED FOR NEARLY 9 YEARS. NOMINAL LONGEVITY FOR THIS MODEL IS 9-10 YEARS. TECHNICAL SERVICES SUSPECTED NORMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297626 ↗
• MalfunctionMay 25, 2023Failure to Capture; Over-Sensing; High Capture Threshold; Interrogation Problem; Failure to Capture; Over-Sensing; High Capture Threshold; Interrogation Problem

  IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL OF THIS PACEMAKER SYSTEM. TECHNICAL SERVICES (TS) REVIEWED ELECTROGRAM (EGM) AND NOTED THAT THERE WAS DIFFICULTY WITH OBTAINING CORRECT TELEMETRY BECAUSE IT WAS DIFFICULT TO READ THE PACING AND SENSING MARKERS AS WELL AS OVERSENSING. AFTER TROUBLESHOOTING IN CLINIC, IT WAS FOUND THAT THE THRESHOLD HAD GONE UP AND THERE WAS INTERMITTENT CAPTURE OF THE RV LEAD. THE OUTPUT WAS INCREASED BY REPROGRAMMING AND RESOLUTION WAS OBTAINED. THIS PATIENT HAD INTRINSIC SENSED BEAT COMING THROUGH. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THIS DEVICE WAS EXPLANTED ELECTIVELY FOR NORMAL BATTERY DEPLETION (NBD). ANOTHER PACEMAKER WAS SUCCESSFULLY PLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF SCHEDULED REPLACEMENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004138 ↗
• InjuryJan 26, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD). IT WAS NOTED THAT THERE WERE OUT-OF-RANGE PACE LEAD IMPEDANCE (PLI) MEASUREMENTS AND ELEVATED CAPTURE THRESHOLD VALUES ON THE RIGHT VENTRICULAR (RV) LEAD. WHEN IN UNIPOLAR CONFIGURATION LEAD MEASUREMENTS AND THRESHOLDS WERE NORMAL. FLUOROSCOPY IMAGING WAS USED TO EXAMINE THE LEAD, BUT NO FRACTURE WAS DETECTED. A NEW PACEMAKER WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248788 ↗
• InjuryNov 10, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER REACHED END OF LIFE (EOL) FROM ONE AND A HALF YEARS IN A SPAN OF FIVE MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED RIGHT VENTRICULAR AUTOMATIC CAPTURE (RVAC) WAS ENABLED. THIS INCONSISTENTLY CREATED A SCENARIO WHERE DEVICE BATTERY DEPLETED SOONER THAN EXPECTED. TS EXPLAINED AT ELECTIVE REPLACEMENT INDICATOR (ERI) DEVICE GOES TO RETRY MODE WITH RVAC AND DEVICE NEEDED TO CALCULATE A CAPACITY TO MAINTAIN RV OUTPUTS AT FIVE VOLTS. THIS IS A UNDESIRED BUT EXPECTED BEHAVIOR OF THE DEVICE. THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15768632 ↗
• InjurySep 12, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD ONE YEAR LEFT FEW MONTHS AGO THEN IT REACHED END OF LIFE (EOL). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THAT THE DEVICE SHOULD BE CHANGED OUT BEFORE EOL AND AS BATTERY CONTINUES TO DEPLETE, EVENTUALLY WILL NOT BE ABLE TO SUPPORT PROGRAMMED OUTPUT, AND WILL JUST DELIVERS WHAT IT CAN. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS SURGICALLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407314 ↗
• InjurySep 12, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER LONGEVITY DROPPED FROM TWO YEARS TO END OF LIFE (EOL) IN A SPAN OF SIX MONTHS. FURTHER, THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401847 ↗
• InjuryAug 29, 2022Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED TO RESOLVE THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317270 ↗
• InjuryMay 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE PACEMAKER DEVICE EXPERIENCED SHORTNESS OF BREATH (SOB) AND THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION (PBD). AN IMMEDIATE REPLACEMENT PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538985 ↗
• MalfunctionMay 27, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE EXHIBITED LONGEVITY CALCULATION FROM 2 YEARS AT THE BEGINNING AND .5 YEARS AT THE END OF EVALUATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED GAS GAUGE MEASUREMENTS AND VARIOUS REASON WHY THERE MAYBE FLUCTUATION. THERE IS NO INTERVENTION INFORMATION AVAILABLE TO DATE AND THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14529802 ↗
• MalfunctionMay 25, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT LONGEVITY OF THIS DEVICE SUDDENLY DROPPED FROM 1.5 YEARS TO ELECTIVE REPLACEMENT TIME (ERT) IN JUST FOUR MONTHS. SINCE THE DEVICE REACHED ERT RAPIDLY, IMMEDIATE BATTERY REPLACEMENT WAS RECOMMENDED. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501430 ↗
• InjuryMay 5, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD 1.5 YEARS REMAINING A WEEK AGO THEN TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI). THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291020 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PULSE GENERATOR WAS EXPLANTED APPROXIMATELY EIGHT YEARS AFTER IMPLANT. A NEW NON-BSC PULSE GENERATOR WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107660 ↗
• MalfunctionMar 4, 2022Signal Artifact/Noise; Over-Sensing; Pacing Problem; Defective Device; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Defective Device

  IT WAS REPORTED THAT DOING A PACEMAKER CHANGE OUT, A POLARITY CHANGE WAS OBSERVED WITH NO KNOWN REASON. THIS CAUSED POSSIBLE NOISE OVERSENSING AND FINALLY FIVE SECONDS OF ASYSTOLE WERE EXPERIENCED BY THE PATIENT UNTIL THE LEAD WAS CONNECTED TO THE PACING SYSTEM ANALYZER. IT WAS CONFIRMED THAT THE PATIENT IS FINE AFTER THE PROCEDURE. THE NEW DEVICE WAS SUCCESSFULLY IMPLANTED AND THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 13675709 ↗
• MalfunctionJan 1, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED ONE AND A HALF YEAR REMAINING, HOWEVER, ABOUT A MONTH AGO IT SHOWED LESS THAN SIX MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED MAGNET RATE DURING DEVICE CHECK WERE BOTH THE SAME AT 100 PPM AN THAT THIS INDICATES ONE YEAR OR MORE REMAINING. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13137404 ↗
• InjuryOct 15, 2021Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE CONCERNS REGARDING ALLEGED PREMATURE BATTERY DEPLETION OF THIS PACEMAKER. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643481 ↗
• InjuryAug 3, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE DROPPED ITS LONGEVITY FOR TWO YEARS IN A SPAN OF SIX MONTHS. MOREOVER, MAGNET RATE WAS AT NINETY SEVERAL MONTHS AGO. ALSO, IT WAS NOTED THAT THE PATIENT DEVICE WAS CHECKED MULTIPLE TIMES IN THE LAST FOUR TO FIVE MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THEN DISCUSSED THAT INTERROGATING THE DEVICE CAN PULL THE VOLTAGE DOWN. THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AND WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271952 ↗
• MalfunctionAug 3, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER PREVIOUSLY SHOWED ONE YEAR REMAINING LONGEVITY. DURING THE RECENT CHECK, THE DEVICE SHOWED TWO AND A HALF YEARS REMAINING LONGEVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED TO DO A SAVE TO DISK ANALYSIS. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AND A NEW DEVICE WAS PLACED. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271921 ↗
• MalfunctionAug 3, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER BATTERY STATUS WAS FLUCTUATING BETWEEN TWO YEARS AND LESS THAN SIX MONTHS. MOREOVER, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED MAGNET RATE WAS AT A HUNDRED AND EXPLAINED THAT MAGNET RATE IS MORE RELIABLE INDICATOR THAN THE GAS GAUGE. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271305 ↗
• InjuryMay 4, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD ONE YEAR REMAINING LONGEVITY A YEAR AGO. DURING THE RECENT CHECK, THE DEVICE WAS STILL AT ONE YEAR REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE HAS BEEN IMPLANTED FOR TEN YEARS. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS LATCHED. THE PATIENT WILL BE SEEN IN 90 DAYS. TO THIS DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11774332 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM WAS EXPLANTED. NO PRODUCT ALLEGATIONS HAVE BEEN RECEIVED AT THIS TIME. A NEW SYSTEM WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661692 ↗
• InjuryApr 13, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (PACEMAKER) EXHIBITED PREMATURE BATTERY DEPLETION. THE PATIENT CAME TO THE HOSPITAL AS HE FELT FATIGUED. THIS DEVICE WAS ANALYZED AND THE BATTERY APPEARED TO HAVE PREMATURELY DEPLETED AS IT HAD REACHED END OF LIFE STATUS. THIS DEVICE REMAINED IN SERVICE AND IMMEDIATE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED, REPLACED AND IT IS NOT EXPECTED TO BE RETURNED AS IT WAS DISCARDED AT THE MEDICAL FACILITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fatigue

  MAUDE report 11661527 ↗
• InjuryJan 26, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED TWO YEARS IN LONGEVITY LAST DEVICE CHECK WHICH WAS SIX MONTHS AGO. HOWEVER, RECENTLY THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). MOREOVER, IT WAS NOTED THAT THE OUTPUT WAS AT FIVE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT LIKELY THRESHOLD DID INCREASED THAT COULD CAUSE THE DECREASE IN LONGEVITY. TS THEN SUGGESTED TO CHECK LEAD TREND AND ADVISED DEVICE SHOULD BE REPLACED. TO DATE, THIS DEVCIE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11233444 ↗
• InjuryJan 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11104341 ↗
• InjuryOct 20, 2020Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING AN IN-OFFICE VISIT THE PATIENT WITH THIS DEVICE, WHILE ALREADY SITTING IN A CHAIR, EXHIBITED A SYNCOPAL EPISODE DURING AUTOMATIC THRESHOLD TESTING. THE PATIENT INCURRED NO INJURY OR ADVERSE EFFECTS DUE TO THE PERIOD OF ASYSTOLE. THE FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION AND REPORTED NO KNOWN PROGRAMMING CHANGES AND THIS HAD BEEN THE FIRST EPISODE OF THIS NATURE. DURING THRESHOLD TESTING, THE PACING CAPTURE WAS ABSENT FOR SEVERAL BEATS AND AUTO CAPTURE FEATURE WAS NOTED AS OFF. DATA WAS SENT FOR A TECHNICAL SERVICES (TS) REVIEW OF PERFORMANCE. THE TS REVIEW NOTED THAT PRIOR TO TURING OFF AUTO CAPTURE (AC) THE DEVICE WAS AT .9V AT 0.4 MSEC MEANING AC THRESHOLD WOULD HAVE BEEN 0.4V AT 0.4MSEC. THE PROGRAMMER COMMANDED TEST FOR AUTOMATIC CAPTURE DOES 5 WARM UP PACES PLUS 12 INITIALIZATION PACES AT 3.5V WITHOUT BACK UP PACES. AFTER THE WARM UP AND INITIALIZATION PULSES AT 3.5V, THE TESTS ADDS 0.5V TO THRESHOLD WHICH WAS 0.4V TO START ITS DECREMENT EVERY 3 PULSES, THAT IS NOT PROGRAMMABLE. IT WAS UNKNOWN IF THE STRIPS SENT FOR REVIEW WERE GATHERED DURING THE TEST TO KNOW THE OUTPUT OR IF THE SITE WAS ACTUALLY PERFORMING A COMMANDED THRE

  Patient problems: Syncope

  MAUDE report 10708342 ↗
• InjuryOct 12, 2020Premature Discharge of Battery; High Capture Threshold; Premature Discharge of Battery; High Capture Threshold

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 10668006 ↗