ALTRUA™ 2 DR S702Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00802526559341), received between Feb 2, 2019 and Sep 24, 2022 — classified as 21 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (17 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.

• InjurySep 24, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS EXPECTED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476024 ↗
• InjuryAug 15, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY. THE ESTIMATED BATTERY LONGEVITY WAS NOTED TO HAVE DECREASED FROM 4.5 YEARS TO ELECTIVE REPLACEMENT INDICATOR (ERI) BETWEEN DEVICE FOLLOW-UPS. THIS PACEMAKER WAS SUCCESSFULLY REPLACED AND IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225161 ↗
• InjuryApr 9, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THE PATIENT EXPERIENCED DIZZINESS AND FAINTING. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 14067540 ↗
• InjuryJan 2, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE WAS EXPLANTED AND REPLACED FOR PREMATURE BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS EXPECTED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13138713 ↗
• MalfunctionJan 1, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT BETWEEN REGULAR FOLLOW-UP APPOINTMENTS, THE PHYSICIAN NOTED A SIGNIFICANT DECREASE IN LONGEVITY AND THE DEVICE WAS FOUND TO BE EXHIBITING THE ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS SUSPECTED THE DEPLETION WAS PREMATURE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13137324 ↗
• InjuryOct 19, 2021Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE WAS SUSPECTED TO BE EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. BETWEEN FOLLOW-UP VISITS, A DECREASE OF APPROXIMATELY 3.5 YEARS IN THE BATTERY'S LONGEVITY WAS OBSERVED. THE LONGEVITY IS NOW SHOWING APPROXIMATELY 3 MONTHS REMAINING, WITHOUT ANY CHANGES IN DEVICE SETTINGS. A COPY OF DEVICE MEMORY WAS SAVED AND SUBMITTED TO TECHNICAL SERVICES (TS) FOR FURTHER BATTERY ANALYSIS. A TS CONSULTANT CONFIRMED THAT THE POWER CONSUMPTION HAS BEEN INCREASING ABNORMALLY; THEREFORE, CONFIRMING PREMATURE BATTERY DEPLETION. DUE TO THIS ANOMALY, DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE CURRENTLY REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12659835 ↗
• InjurySep 22, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS SUSPECTED TO BE PREMATURELY DEPLETING. AT THIS TIME, NO INTERVENTION HAS BEEN PERFORMED AND THE PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED SURGICAL INTERVENTION WAS LATER PERFORMED AND THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515819 ↗
• InjuryAug 5, 2021Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY DURING A ROUTINE FOLLOW UP. REMAINING LONGEVITY DECREASED OVER THREE YEARS WITHIN A ONE YEAR PERIOD. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285669 ↗
• InjuryJul 8, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. THIS DEVICE WAS REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. ANOTHER BOSTON SCIENTIFIC DEVICE WAS IMPLANTED WITHOUT ADDITIONAL ADVERSE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139319 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ABOUT TWO WEEKS POST-IMPLANT, THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPERIENCED AN INFECTION AND EROSION AT THE DEVICE POCKET. THE DEVICE WAS EXPLANTED AND A NEW PACEMAKER WAS IMPLANTED ON THE PATIENT'S OTHER SIDE USING THE EXISTING LEADS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS PLANNED TO BE RETURNED FOR DISPOSAL.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 11750741 ↗
• MalfunctionFeb 5, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION AS THE ELECTIVE REPLACEMENT INDICATOR WAS TRIGGERED APPROXIMATELY ONE AND A HALF YEARS AFTER IMPLANT. CURRENTLY, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11290121 ↗
• InjuryJan 22, 2021Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT WITH THIRD DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS IMPLANTED WITH THIS DEVICE. DURING A POST IMPLANT FOLLOW-UP, THE PATIENT REPORTED DISCOMFORT, AT WHICH TIME AN ELECTROGRAM REVIEW WOULD ILLUSTRATE RETURN OF THE PRE IMPLANTED, AV BLOCK THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE SO AS TO FURTHER TEST THE SYSTEM, TO INCLUDE ASSOCIATED LEAD TESTING. ALL LEAD PARAMETERS WERE FAVORABLE HOWEVER RECONNECTING TO THE DEVICE WOULD CONFIRM THE PREVIOUS OBSERVATIONS AND FOR THIS REASON, THE PHYSICIAN ELECTED TO REMOVE AND REPLACE THIS DEVICE. NO LEAD CHANGES WERE REQUIRED AND THE EXPLANTED DEVICE WAS LATER RETURNED FOR LABORATORY ANALYSIS. NO OTHER RESULTING ADVERSE EFFECTS WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH THE PATIENT REPORTED AS STABLE.

  Patient problems: Complete Heart Block; Discomfort; Heart Block

  MAUDE report 11218836 ↗
• InjuryJan 6, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS IMPLANTED FOR LESS THAN FIVE YEARS. PREMATURE BATTERY DEPLETION WAS SUSPECTED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 11128128 ↗
• InjuryJan 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING PREMATURE BATTERY DEPLETION. AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST THAT INTERVENTION HAS BEEN PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11104637 ↗
• InjurySep 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER BATTERY APPEARED TO BE PREMATURELY DEPLETING BASED ON PREVIOUS BATTERY LONGEVITY CHECKS. SUBSEQUENTLY, SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT AND REPLACE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10606383 ↗
• InjuryApr 5, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SYNCOPE AND WAS FOAMING AT THE MOUTH. IT WAS NOTED THAT THE SAME DAY THERE WAS AN EPISODE OF NOISE AND OVERSENSING ON THE VENTRICULAR ELECTROCARDIOGRAM. THE NOISE WAS ABLE TO BE REPRODUCED WITH MANIPULATION, HOWEVER NO OVERSENSING WAS SEEN. IT WAS NOTED THAT THE SIGNAL AMPLITUDES HAD DECREASED ON THE VENTRICULAR ELECTROCARDIOGRAM. POSSIBLE LEAD DAMAGE WAS SUSPECTED BUT NOT CONFIRMED. THE LEAD MODEL/SERIAL WAS NOT OBTAINED. A REVIEW OF THE CASE BY TECHNICAL SERVICES (TS) CONFIRMED NOISE, ALTHOUGH THE ROOT CAUSE WAS NOT CLEAR. OVERSENSING WAS ALSO SEEN, ALTHOUGH THE PATIENT HAD AN INTRINSIC RHYTHM, THUS NO ASYSTOLE WAS SEEN. TS DISCUSSED NOISE WHICH WAS SEEN IN THE TWO EPISODES SENT IN FOR REVIEW POTENTIALLY RELATED TO MECHANICAL IMPAIRMENT AS WELL AS MYOPOTENTIAL OR BACKGROUND NOISE. IN ADDITION IT WAS NOTED THAT THERE WAS A FLUCTUATION IN PACE IMPEDANCE MEASUREMENTS, BUT VALUES WERE WITHIN RANGE. TS DISCUSSED PERFORMING ADDITIONAL MANEUVERS TO DETERMINE THE ROOT CAUSE OF THIS CASE. ADDITIONAL INFORMATION NOTED THAT THE PHYSICIAN PERFORMED THE SUGGESTED STEPS BY TECHNICAL SERVICES AND BELIEVED THAT THE NOISE WAS MY

  Patient problems: Syncope

  MAUDE report 9926874 ↗
• InjuryJan 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED, AND A TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9550719 ↗
• MalfunctionAug 7, 2019Over-Sensing; Connection Problem; Device Sensing Problem; Over-Sensing; Connection Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THIS PACEMAKER EXHIBITED OVERSENSING OF NOISE WHEN THE RV LEAD WAS CONNECTED. THE PACEMAKER WAS REMOVED AND REPLACED PRIOR TO POCKET CLOSURE AND WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872200 ↗
• InjuryJul 16, 2019Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THIS DEVICE HAD BEEN IMPLANTED WITH NORMAL PARAMETERS CONFIRMED AT IMPLANT AND SET IN UNIPOLAR PROGRAMMING, AS IT WAS ASSUMED THE ORIGINAL DEVICE HAD BEEN IN UNIPOLAR. DUE TO THE PROGRAMMING ANOMALY WITH THE NEW DEVICE (UNIPOLAR VS BIPOLAR PROGRAMMING) NO PACING PULSES WERE OBSERVED POST CONNECTION. APPROXIMATELY ONE MONTH POST IMPLANT, THE PATIENT WAS ADMITTED FOR SYNCOPE AND CARDIAC ARREST. DURING SYSTEM ASSESSMENTS POST ADMISSION, THE PHYSICIAN FOUND INTERFERENCE SIGNALS. IT WAS ALSO LEARNED THE PATIENT WAS VERY ACTIVE WITH EXCESSIVE UPPER LIMB MOVEMENT DURING PHYSICIAN ACTIVITY. A CHEST X-RAY ILLUSTRATED ABNORMAL IMAGES OF THE LEAD AT THE COLLAR BONE. THE ASSOCIATED IMPLANTED LEAD IS A NON BOSTON SCIENTIFIC PRODUCT. THE PHYSICIAN ELECTED TO REPLACE THE ENTIRE SYSTEM. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED. NO INFORMATION WAS PROVIDED ON THE ASSOCIATED LEAD MANUFACTURE OR MODEL/SERIAL NUMBERS. THE REPLACEMENT WAS SUCCESSFUL AND THE ISSUE RESOLVED.

  Patient problems: Cardiac Arrest; Syncope

  MAUDE report 8794055 ↗
• InjuryJun 20, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE BATTERY HAD ALLEGEDLY PREMATURELY DEPLETED. THE DEVICE IS PENDING EXPLANT TO RESOLVE THE EVENT AT AN UNSPECIFIED FUTURE DATE. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8718746 ↗
• MalfunctionMay 6, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS BOXED DEVICE WAS INTERROGATED AS PART OF CHINA'S CUSTOMS PROCESS FOR RECEIVING MEDICAL DEVICES. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN SAFETY CORE STATUS. AN ERROR SCREEN WAS SUBMITTED TO TECHNICAL SERVICES FOR REVIEW AND IT WAS DETERMINED A MEMORY ERROR HAD OCCURRED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 8584577 ↗
• InjuryApr 29, 2019Over-Sensing; Pacing Problem; Device Sensing Problem; High Capture Threshold; Over-Sensing; Pacing Problem; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WITH THIS DEVICE SYSTEM WILL LIKELY BE SCHEDULED FOR REPLACEMENT DUE TO JUMPY UNRESOLVED, IMPEDANCE MEASUREMENTS. THE FIELD REPRESENTATIVE REPORTED THE PATIENT ALSO HAS SEVERAL, UNIDENTIFIED, ABANDONED IMPLANTED LEADS. DURING THE RECENT FOLLOW-UP, NOISE ON THE RIGHT ATRIAL LEAD WAS OBSERVED DURING AN INTERROGATION SESSION. ADDITIONALLY, TWO SYNCOPE EVENTS OCCURRED WITHIN THE PAST THREE WEEKS; DATES/TIMES UNKNOWN. THE PATIENT WAS HOSPITALIZED FOLLOWING THE FIRST SYNCOPE; SURFACE ELECTROGRAM WAS WITHOUT ABNORMALITIES. THE DEVICE WAS THEN REPROGRAMMED TO TURN OFF THE AMV SENSOR AND THE PATIENT RELEASED. THE SECOND SYNCOPE ILLUSTRATED A VENTRICULAR RHYTHM BELOW THE LOWER RATE LIMIT. AV BLOCK III WAS PRESENT ON SURFACE ECG IN HOSPITAL. VENTRICULAR RHYTHM OF 26 BPM. AGAIN, THE INTERROGATION OF DEVICE WAS WITHOUT ABNORMALITIES AND SHOWED PROPER THRESHOLD. OVERSENSING WAS ASSUMED AS CAUSE FOR STIMULATION INHIBITION: REPROGRAMMING, RV SENSITIVITY SET TO 4.0 V WITH PROPER RV SENSING. FIELD FOLLOW UP HAS CONFIRMED THE SYSTEM, DEVICE AND ACTIVE LEADS, WILL BE EXPLANTED AND REPLACED AT A LATER DATE AND, AT ANOTHER MEDICAL FACILITY. THE PATIENT IS CURRENTLY ON HO

  Patient problems: Syncope

  MAUDE report 8562544 ↗
• InjuryApr 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION. AFTER 3 YEARS OF IMPLANT THE ESTIMATED REMAINING LONGEVITY WAS FOUND AT APPROXIMATELY 7 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA NOTING POWER CONSUMPTION HAD BEEN INCREASING OVER THE PREVIOUS YEAR; DEVICE REPLACEMENT WAS RECOMMENDED. A REVISION PROCEDURE WAS LATER PERFORMED WHEREIN THIS DEVICE WAS EXPLANTED; NO FURTHER DETAILS COULD BE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509305 ↗
• InjuryApr 11, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER IS BEHAVING IN A MANNER CONSISTENT WITH A RECORDED CODE 1003 INDICATIVE OF PREMATURE BATTERY DEPLETION. DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC RECEIVED DEVICE AND COMPLETED ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8505087 ↗
• MalfunctionMar 14, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED CODE 1003 INDICATIVE OF BATTERY VOLTAGE BEING TOO LOW FOR THE PROJECTED REMAINING CAPACITY. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME AND THE PACEMAKER REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8422198 ↗