ALTRUA™ 20 S201Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00802526484384), received between Oct 10, 2017 and Jul 19, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 19, 2022Signal Artifact/Noise; Over-Sensing; Connection Problem; Impedance Problem; Material Integrity Problem; High Capture Threshold; Signal Artifact/Noise; Over-Sensing; Connection Problem; Impedance Problem; Material Integrity Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (PACEMAKER) WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION, BUT ALSO DUE TO SUSPICIONS OF INTERACTION ISSUES WITH THE LEFT ATRIUM (LA) LEAD. REPORTEDLY, IMPEDANCE ISSUES, HIGH CAPTURE THRESHOLDS AND NOISE EVENTS WERE NOTICED FOR MONTHS, AND IT WAS BELIEVED THERE WAS AN INTEGRITY ISSUE WITH THE LA LEAD. HOWEVER, DURING THE REPLACEMENT PROCEDURE, THE LEAD WAS TESTED IN THE ANALYZER AND NO INADEQUATE MEASUREMENTS WERE NOTICED. THUS, IT WAS DECIDED TO KEEP THE LEAD IMPLANTED AND ONLY THE PACEMAKER WAS REPLACED. IN ADDITION, IT WAS STATED THAT THE PATIENT FELL A FEW TIMES OVER THE LAST MONTHS, NOT RELATED TO THIS PACEMAKER PERFORMANCE, AND IT WAS SUSPECTED THAT THIS CAUSED THE CONNECTION ISSUE. THIS PACEMAKER IS EXPECTED TO BE RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059875 ↗
• InjuryOct 12, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE DECLARED END OF LIFE (EOL). AT THE BEGINNING OF THIS YEAR, THE BATTERY LONGEVITY SHOWED TWO YEARS REMAINING, WITH ONLY 8% PACING. THE DEVICE HAD FIRST DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) LAST MONTH, AND THEN RECENTLY DECLARED EOL. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619381 ↗
• InjuryJun 23, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD LESS THAN HALF A YEAR LONGEVITY REMAINING BUT NOW SHOWED TWO YEARS LONGEVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CURRENT BINS CAUSING CHANGE IN PROGRAMMER ESTIMATE LONGEVITY AND ADVISED THAT MAGNET RATE SHOWED DEVICE IS LESS THAN A YEAR. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT BATTERY STATUS INDICATORS WERE DIFFERENT THAN EXPECTED. ANY CHANGES IN THESE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION AND THEREFORE THE REMAINING LONGEVITY ESTIMATE. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED AND WAS RETURNED.

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

  MAUDE report 12054364 ↗
• InjuryApr 13, 2021Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER, IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD, EXHIBITED NOISE WITH OVERSENSING. INSULATION BREACH WAS NOTED ON THE RV LEAD. THE PACEMAKER WAS EXPLANTED, THE RV LEAD WAS SURGICALLY ABANDONED, AND A NEW SYSTEM WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661830 ↗
• MalfunctionOct 28, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS ASKED TO REVIEW A POSSIBLE LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) LEAD. TS CONFIRMED LOC ON THE RV LEAD, AND PROGRAMMING OPTIONS WERE DISCUSSED. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10752601 ↗
• InjuryJul 3, 2020Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE FIELD WAS UNABLE TO ESTABLISH TELEMETRY WITH THIS PACEMAKER. SURGICAL INTERVENTION WAS THEN PERFORMED TO EXPLANT AND REPLACED THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10228066 ↗
• MalfunctionOct 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER'S BATTERY SHOWED LESS THAN SIX MONTHS WITH MAGNET RATE OF NINETY. THE HEALTH CARE PROFESSIONAL (HCP) ASKED FOR A MORE PRECISE ESTIMATE. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE DEVICE BEHAVIOR WHEN IT REACHED ERI. AN ATTEMPT TO OBTAIN ADDITIONAL PERTINENT INFORMATION WAS UNSUCCESSFUL. TO DATE, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6936999 ↗