ALTRUA™ 60 S602Recalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00802526484476), received between Apr 26, 2016 and Apr 14, 2026 — classified as 1 death, 96 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (47 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 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Data Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A CLINIC VISIT, TELEMETRY ISSUES WAS REPORTED WHILE INTERROGATING THIS PACEMAKER. IT WAS NOTED THAT DURING INTERROGATION, THE PACEMAKER DISPLAYED PATIENT HEART RATE TO BE LESS THAN 30 BEATS PER MINUTE (BPM) EVEN THOUGH MARKERS SHOW RATE TO BE AROUND 80 BPM. IT WAS ALSO NOTED THAT THE ELECTROGRAM (EGM) WOULD DROP OUT WHEN A THRESHOLD TEST WAS ATTEMPTED. TECHNICAL SERVICES (TS) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. TS PROVIDED TROUBLESHOOTING RECOMMENDATIONS. AT THIS TIME, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876170 ↗
• MalfunctionMar 19, 2026Battery Problem; Data Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A DEVICE INEFFICIENCY DUE TO LOW BATTERY. AS OF THIS TIME, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639074 ↗
• MalfunctionDec 24, 2025Under-Sensing; Impedance Problem; Interrogation Problem; Under-Sensing; Impedance Problem; Interrogation Problem

  IT WAS REPORTED THAT THE PACEMAKER SYSTEM EXHIBITED UNDERSENSING OF THE P WAVE, AND IMPEDANCE MEASUREMENTS COULD NOT BE OBTAINED. THE PATIENT ALSO REPORTED A HISTORY OF TELEMETRY DIFFICULTIES. MULTIPLE TROUBLESHOOTING STEPS WERE ATTEMPTED, HOWEVER, TELEMETRY COULD NOT BE MAINTAINED. TECHNICAL SERVICES (TS) SUGGESTED PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886615 ↗
• InjuryMar 24, 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 THE SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21683890 ↗
• MalfunctionMar 11, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS BEING REMOTELY INTERROGATED WITH A CONSULT DEVICE. THE INTERROGATION WAS UNABLE TO BE SUCCESSFULLY COMPLETELY. SUBSEQUENTLY, THE DEVICE WAS INTERROGATED WITH A PROGRAMMER AND THIS DEVICE MAY HAVE REACHED A BATTERY STATUS OF 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 21578135 ↗
• InjuryJan 2, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER SYSTEM, IMPLANTED WITH NON BOSTON SCIENTIFIC LEADS, WAS ADMITTED TO THE HOSPITAL AND TELEMETRY REVEALED 6-8 SECOND PAUSES IN PACING. THE PACEMAKER WAS PROGRAMMED TO A FIXED OUTPUT OF 2.5V, AND THRESHOLD MEASUREMENT WAS 0.6V. SENSITIVITY WAS PROGRAMMED TO 2.5MV. IMPEDANCE MEASUREMENTS WERE STABLE AT AROUND 550 OHMS, AND THERE WERE NO STORED EVENTS. ELECTROLYTE LEVELS WERE NOT CHECKED, AND THE PATIENT HAD AN UNSPECIFIED MEDICAL CONDITION UNRELATED TO THE DEVICE. IT WAS NOTED THAT THE NON BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD WAS KNOWN TO BE FRACTURED A CENTIMETER FROM THE TIP OF THE LEAD, HOWEVER THE ONSET WAS NOT KNOWN. THERE WAS NO LEAD SAFETY SWITCH (LSS) NOTED AND THE DEVICE WAS SENSING IN BIPOLAR. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING/PROGRAMMING OPTIONS AND POSSIBLE CAUSES, INCLUDING POSSIBLE OVERSENSING. THIS PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 21063362 ↗
• MalfunctionNov 20, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED NOISE ON BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD CHANNELS. UPON REVIEW, TECHNICAL SERVICES (TS) NOTED THE NOISE WAS OVERSENSED ON THE RA CHANNEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20741666 ↗
• InjurySep 6, 2024Difficult to Remove; Connection Problem; Difficult to Remove; Connection Problem

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM WAS SCHEDULED FOR A ROUTINE BATTERY REPLACEMENT PROCEDURE. AFTER UNSCREWING THE SETSCREWS FROM THE RIGHT ATRIAL (RA) PORT, THE TERMINAL PIN REMAINED IN THE HEADER AND SEPARATED FROM THE LEAD BODY UPON ATTEMPTING TO DISCONNECT THE RA LEAD. THE RA LEAD FRACTURED, AND THE CONDUCTOR WIRES CAME UNDONE. THE PACEMAKER AND RA TERMINAL PIN IN THE HEADER WERE EXPLANTED, AND THE DECISION WAS MADE TO CUT THE EXPOSED WIRING AND SURGICALLY ABANDON THE RA LEAD. THE NEW PACEMAKER AND A NEW RA LEAD WERE SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164314 ↗
• MalfunctionMar 21, 2024Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE PACEMAKER EXHIBITED LOSS OF CAPTURE ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS. UNDERSENSING WAS ALSO NOTED ON THE RV LEAD. THE PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956565 ↗
• MalfunctionJan 30, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED FOUR YEARS REMAINING TO ONE YEAR REMAINING IN A SPAN OF SEVEN MONTHS. THIS DEVICE ALSO TRIGGERED EXPLANT INDICATOR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WALKED THE REPRESENTATIVE THROUGH PEN DRIVE NAVIGATION AND CONFIRMED THAT THE FULL DOWNLOAD OF ALL DEVICE MEMORY WAS PERFORMED. ADDITIONAL INFORMATION WAS OBTAINED WHICH INDICATED THAT THE ANALYSIS SHOWED NORMAL BATTERY DEPLETION. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606749 ↗
• MalfunctionDec 19, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER DID NOT PACE WHEN REQUIRED, VENTRICULAR PACING WAS DELAYED. TECHNICAL SERVICES (TS) WAS CONSULTED AND REVIEWED POSSIBLE REASONS FOR THE EXHIBITED BEHAVIOR. THIS PACEMAKER WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AFTER APPROXIMATELY TEN YEARS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18359244 ↗
• InjuryJun 15, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER LONGEVITY THREE MONTHS AGO WAS ONE AND A HALF YEAR REMAINING AND RECENTLY LONGEVITY WAS NOTED AT MORE THAN FIVE YEARS WITH OUTPUT IS AUTO 5 VOLTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED AND DISCUSSED THAT DEVICE DIAGNOSTICS APPEARS NORMAL. THIS IS POSSIBLY DEVICE RESET THAT CLEARS BATTERY, DEVICE LOGBOOK AND DAILY MEASUREMENTS. MOREOVER, THE AUTO OUTPUT WAS LIKELY ASSOCIATED WITH THE RESET. TS THEN SUGGESTED TO BRING PATIENT IN TO TEST THRESHOLD AND PROGRAM APPROPRIATELY. FURTHERMORE, TS SUGGESTED TO REPLACE DEVICE IF DIAGNOSTIC HAVE NOT RETURNED IN TWO TO FOUR WEEKS. THE DEVICE REMAINS IN SERVICE AND HAS BEEN IMPLANTED FOR ALMOST 15 YEARS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133518 ↗
• MalfunctionMay 8, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING EXPLANT PROCEDURE, THE PHYSICIAN WAS USING ELECTROCAUTERY AND THIS PACEMAKER EXHIBITED PACING INHIBITION FOR MORE THAN TWO SECONDS. TECHNICAL SERVICES (TS) DISCUSSED IT COULD BE THE DEVICE SENSED EXTRA ENERGY AND REACTED TO PREVENT ENERGY FROM BEING DELIVERED IN AN UNINTENDED LOCATION. THIS PACEMAKER WAS SUCCESSFULLY EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 16891157 ↗
• MalfunctionMar 29, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS CONCERN FOR PREMATURE BATTERY DEPLETION. THE LONGEVITY WAS THREE YEARS IN NOVEMBER 2021 AND HAD RECENTLY REACHED END OF LIFE. IT WAS NOTED THAT THE PATIENT HAD HIGH PACING THRESHOLDS. THE PACEMAKER WAS IMPLANTED IN AUGUST 2010 AND HAD ALREADY EXCEEDED LONGEVITY EXPECTATIONS. THE DEVICE WAS REPLACED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635790 ↗
• InjuryFeb 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE IMPLANTED PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD WERE REPLACED DUE TO AN UNSPECIFIED ISSUE. THE RV LEAD WAS CAPPED AND REMAINS IN THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LEAD WAS REPLACED DUE TO A HIGH THRESHOLD (2.6 V AT 1.0 MS). INITIALLY, THE CAPTURE THRESHOLD WASN'T AN ISSUE FOR THERAPY; HOWEVER, OVER TIME THE PATIENT NEEDED A HIGHER PERCENTAGE OF PACING. THE PACEMAKER WAS ELECTIVELY REPLACED DUE TO APPROACHING END-OF-LIFE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417915 ↗
• InjuryOct 24, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED A BATTERY STATUS OF 1 YEAR REMAINING WITH A MAGNET RATE OF 90 PACES PER MINUTE (PPM) 10 MONTHS AGO. A DEVICE TECHNICIAN THEN CHANGED THE RIGHT VENTRICULAR (RV) OUTPUT FROM AUTO 2.2 VOLTS TO A FIXED OUTPUT OF 3.0 VOLTS. THE BATTERY STATUS THEN SHOWED 3 YEARS REMAINING WITH A MAGNET RATE OF 90 PPM. THE DEVICE WAS THEN SCHEDULED TO BE EXPLANTED. PRIOR TO EXPLANT OF THE DEVICE, A DEVICE TECHNICIAN PROGRAMMED THE DEVICE TO VVI 40 AND THE BATTERY STATUS WENT TO 4.5 YEARS REMAINING. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE. THE PHYSICIAN REQUESTED MORE INFORMATION REGARDING THE BATTERY STATUS BEHAVIOR. A COPY OF DEVICE DATA WAS SUBMITTED TO TECHNICAL SERVICES (TS) FOR REVIEW. REVIEW OF STORED DEVICE DATA NOTED THAT THE DATA SENT DID NOT CONFIRM THAT ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN REACHED. TS DISCUSSED THE DEVICE BATTERY STATUS INDICATORS AND LONGEVITY REMAINING THAT IS ESTIMATED BY THE PROGRAMMER. TS THEN INDICATED THAT THE REPORTED CLINICAL OBSERVATIONS WERE A RESULT OF THE CHANGE IN OUTPUTS, WHICH, IMPACTED THE LONGEVITY REMAINING ESTIMATED BY THE PROGRAMMER. NO ADDITIONAL ADVERSE PATIENT EFFECTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657820 ↗
• InjuryOct 12, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER PRESENTED TO THE HOSPITAL FOLLOWING A SYNCOPE EVENT. THIS PATIENT WAS NOTED TO BE PACING DEPENDENT. THE PACING IMPEDANCE MEASUREMENTS WERE ALSO NOTED TO HAVE BEEN DECREASED RECENTLY. DURING THE DEVICE CHECK, THE AUTO CAPTURE FEATURE WAS PROGRAMMED OFF. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 15591200 ↗
• InjurySep 29, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE MAGNET RATE OF THIS PACEMAKER DROPPED TO NINETY BEATS PER MINUTE AND THEN BACK TO A HUNDRED BEATS PER MINUTE AFTER SEVERAL MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. HOWEVER, THERE WAS NO MEMORY DATA FOR THE RESET COUNTERS IS AVAILABLE. THE MEMORY DATA RETURNED FOR THE DEVICE APPEARS TO BE INCOMPLETE AND MISSING KEY MEMORY LOCATIONS REQUIRED TO PERFORM AN ACCURATE ANALYSIS OF BATTERY PERFORMANCE. THIS DEVICE HAS BEEN IMPLANTED FOR APPROXIMATELY 11.2 YEARS AND MINIMUM EXPECTED LONGEVITY IS APPROXIMATELY 7 YEARS. SINCE THE DEVICE HAS FAR EXCEEDED MINIMUM EXPECTED LONGEVITY CALCULATIONS, IT WAS CONCLUDED THAT ELECTIVE REPLACEMENT TIME (ERT) DECLARATION MAY OCCUR AT ANY TIME. FURTHER, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED RESULTS WITH HEALTH CARE PROFESSIONAL AND SOUNDS LIKE WILL OPT TO CONTINUE THE 7 WEEK CHECKS. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503867 ↗
• MalfunctionSep 24, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE EXHIBITED LONGEVITY CALCULATION FROM LESS THAN FIVE YEARS REMAINING TO LESS THAN A YEAR AFTER TRANS TELEPHONIC MONITORING (TTM). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT TTM IS TYPICALLY MAGNET PLACEMENT ONLY TO ASSESS MAGNET RATE. WITH PROJECTION OF GREATER THAN 5 YEARS AND WOULD EXPECT A MAGNET RATE OF 100 PPM. TS ALSO SUGGESTED TO EVALUATE FUNCTION OF AUTO THRESHOLD IF TURNED ON AND IF THAT WENT INTO SUSPENSION WITH A HIGH OUTPUT AND PATIENT IS PACED AT A HIGH PERCENT THEN THAT COULD CAUSE CHANGES IN PROJECTED LONGEVITY. THE ASSOCIATED INVESTIGATION DETERMINED THAT BATTERY STATUS INDICATORS WERE DIFFERENT THAN EXPECTED BASED ON INFORMATION PROVIDED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477680 ↗
• MalfunctionAug 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED, HOWEVER DISK DATA WAS NOT YET PROVIDED. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION IS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312992 ↗
• InjuryAug 3, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY, BUT THE TIMEFRAME IN WHICH THE CHANGE IN THE ESTIMATED REMAINING BATTERY LONGEVITY WAS OBSERVED, HAS NOT BEEN SPECIFIED. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE. AT THIS TIME, THERE IS NO EVIDENCE THAT SUGGESTS DATA ANALYSIS WAS PERFORMED PRIOR TO THE EXPLANT PROCEDURE TO CONFIRM THE PREMATURE BATTERY DEPLETION (PBD) OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157939 ↗
• InjuryJul 25, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER HAD A STAPHYLOCOCCUS INFECTION. REPORTEDLY, THE PATIENT'S DEVICE HAD TWO WEEKS OF LOW LONGEVITY BATTERY. THE PATIENT ALSO REPORTS OF BEING LIGHT HEADED. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE PACEMAKER WITH THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 15097467 ↗
• InjuryJul 6, 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 AND VEGETATION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14940634 ↗
• InjuryJun 17, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WERE CONCERNS REGARDING ALLEGED PREMATURE BATTERY DEPLETION OF THIS PACEMAKER. AT THE MOST RECENT FOLLOW-UP, SIX MONTHS PRIOR, THE LONGEVITY REMAINING WAS ABOUT 2.5 YEARS. AT THE LATEST CLINIC APPOINTMENT, THE DEVICE HAD MET END OF LIFE SINCE 30APR2022. DATA WAS PROVIDED FOR ANALYSIS AND BOSTON SCIENTIFIC TECHNICAL SERVICES INDICATED THAT THE DEVICE IS FUNCTIONING NORMALLY. THIS DEVICE HAS BEEN IMPLANTED OVER 11 YEARS WHICH IS OVER THE ESTIMATED BATTERY LIFE. THE PLAN IS TO REPLACE THIS DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732277 ↗
• MalfunctionJun 14, 2022Communication or Transmission Problem; Interrogation Problem; Communication or Transmission Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHECK, THIS PACEMAKER WAS UNABLE TO BE INTERROGATED. APPROPRIATE MAGNET RESPONSE WAS VERIFIED. THE PATIENT WILL RETURN TO THE CLINIC IN 1 WEEK FOR A RECHECK. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682945 ↗