ALTRUA™ 20 S204Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00802526499128), received between Nov 7, 2018 and Feb 13, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) LEAD. THE INVOLVED LEAD IS A NON-BOSTON SCIENTIFIC AND HAS BEEN IMPLANTED SINCE 1990. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER EVALUATION OF THIS PATIENT AND LEAD. REPROGRAMMING WAS PERFORMED AND THRESHOLDS WERE INCREASED TO 3 V. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379683 ↗
• MalfunctionSep 12, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WENT FROM ONE YEAR OF LONGEVITY REMAINING TO END-OF-LIFE (EOL) STATUS IN A SPAN OF SIX MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE HIGH LEVEL OF HOW THIS DEVICE MANAGES LONGEVITY AS IT RELATES TO CURRENT BINS. THIS DEVICE WAS LIKELY OPERATING ON THE EDGE OF A CURRENT, THEN A SMALL CHANGE IN POWER CONSUMPTION CAUSED IT TO HOP TO A HIGHER CURRENT BIN, RESULTING IN ELECTIVE REPLACEMENT INDICATOR (ERI). TS STATED THAT THIS IS NOT LIKELY A BATTERY MALFUNCTION BUT AN OUTLIER OBSERVATION DUE TO THE BATTERY MANAGEMENT DESIGN. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730667 ↗
• InjuryJul 28, 2021Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH OVERSENSING PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE. IT WAS NOTED THAT R-WAVES WERE 3.3 MV AND IT WAS PROGRAMMED TO 1.5MV. THE PATIENT WAS EXPERIENCING LIGHTHEADEDNESS. THE PACEMAKER WAS EXPLANTED, THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED, AND A NEW PACEMAKER SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 12243312 ↗
• InjuryJul 23, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER PATIENT EXPERIENCED MULTIPLE SYNCOPAL EPISODES AND PRESENTED TO THE EMERGENCY ROOM. THE DEVICE WAS INTERROGATED AND IT INDICATED INTERMITTENT UNDERSENSING OCCURRED ON THE RIGHT VENTRICULAR (RV) LEAD. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED EVALUATING THE RV LEAD, AS AN ADEQUATE SAFETY MARGIN WAS PROGRAMMED. SUBSEQUENTLY, THE RV LEAD WAS REPROGRAMMED AND THE SENSITIVITY WAS INCREASED. THIS PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope

  MAUDE report 8818785 ↗
• InjuryNov 7, 2018Low impedance; Low impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED LOW RIGHT VENTRICULAR (RV) IMPEDANCE MEASUREMENTS. THE IMPEDANCES WERE NOT OUT OF RANGE, WERE STABLE, AND THE PATIENT WAS OBSERVED AT THAT TIME. THE IMPEDANCE MEASUREMENTS WERE 200 OHMS AND HAD BEEN STABLE BUT CHRONICALLY LOW, AND WAS LATER NOTED TO HAVE DEPLETED THE BATTERY OF THIS PACEMAKER. A SURGICAL REVISION WAS PERFORMED TO REPLACE THE DEVICE DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8048391 ↗