ALTRUA™ 20 S205Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00802526499210), received between Oct 12, 2016 and Oct 13, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2024Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THIS PACEMAKER COULD NOT BE INTERROGATED BY DIFFERENT PROGRAMMERS. DIFFERENT TROUBLESHOOTING OPTIONS WERE DISCUSSED WITH THE DIFFERENT PROGRAMMERS AND STILL THE DEVICE COULD NOT BE INTERROGATED. AN X RAY WAS COMPLETED TO CONFIRM THE DEVICE WAS STILL IMPLANTED. IT WAS RECOMMENDED TO CONSIDER THE PATIENT UNPROTECTED AND REPLACE DEVICE. THE PACEMAKER REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436512 ↗
• MalfunctionJul 11, 2023Signal Artifact/Noise; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED NOISE AND OVERSENSING ON THE VENTRICULAR CHANNEL. HIGH CAPTURE THRESHOLDS WERE NOTED AS WELL. THE INVOLVED RIGHT VENTRICULAR (RV) LEAD IS A NON BOSTON SCIENTIFIC PRODUCT. THE PATIENT REPORTED EXPERIENCING POCKET STIMULATION. A FOLLOW UP WITH CARDIOLOGY WAS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 17302155 ↗
• InjuryJul 13, 2022Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED AN EVENT WERE NOISY SIGNALS WERE OVERSENSED. THERE WAS NO MALFUNCTION RELATED TO THE SYSTEM LEADS. THESE LEADS WERE UNIPOLAR. A NEW SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE WITHOUT ANY PROBLEMS. THE EXISTING SYSTEM WAS NOT REMOVED AND REMAINS IMPLANTED. THE SENSE AND PACE RATE WAS REPROGRAMMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999184 ↗
• MalfunctionApr 22, 2022Signal Artifact/Noise; Over-Sensing; Pacing Problem; Battery Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER AND A NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISE RESULTING IN AN UNKNOWN DURATION OF PACING INHIBITION, AND ATRIAL TACHY RESPONSE (ATR) MODE SWITCHES. THE PATIENT WAS NOTED TO BE RA AND RV PACEMAKER DEPENDENT. PROGRAMMING CHANGES WERE MADE. SUBSEQUENTLY, THE BATTERY STATUS WAS NOTED TO HAVE INCREASED FROM LESS THAN 0.5 YEARS REMAINING TO 1 YEAR REMAINING. TECHNICAL SERVICES (TS) DISCUSSED THE INCREASE IN LONGEVITY WAS LIKELY A RESULT OF THE PROGRAMMING CHANGES THAT WERE MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14182138 ↗
• InjuryNov 3, 2021Adverse 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 SKIN INFECTION WHICH LED TO POCKET EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 12749680 ↗
• InjuryOct 12, 2016Over-Sensing; Pacing Problem; Ambient Noise Problem; Over-Sensing; Pacing Problem; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER AND RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS FROM ANOTHER MANUFACTURER EXHIBITED NOISE AND OVERSENSING LEADING TO PACING INHIBITION. THE NOISE WAS ABLE TO BE REPRODUCED WITH ISOMETRICS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED DECREASING SENSITIVITY IN THE ATRIUM AND VENTRICLE TO INCREASE PACING. THE SYSTEM WAS ABANDONED AND A NEW SYSTEM WAS IMPLANTED IN THE RIGHT SIDE. THE DEVICE WAS LATER EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6021733 ↗