ALTRUA™ 20 S203Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00802526484391), received between Jul 14, 2016 and Jul 7, 2023 — classified as 7 injuries, 7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE FIELD REPRESENTATIVE WAS NOT ABLE TO INTERROGATE THIS PATIENT WITH A PACEMAKER. PACING WAS CONFIRMED AT 100BPM WITH MAGNET APPLICATION USING BOTH THE ELECTROCARDIOGRAM AND EXTERNAL DEFIBRILLATOR. THE PATIENT WAS MOVED TO DIFFERENT LOCATIONS AND MULTIPLE PROGRAMMERS WERE USED AND IT WAS STILL UNSUCCESSFUL. THE ATTENDING PHYSICIAN WAS NOTIFIED AND WILL CONSULT WITH THE ELECTROPHYSIOLOGIST. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278401 ↗
• MalfunctionJul 26, 2022Failure to Capture; High impedance; Over-Sensing; Under-Sensing; Failure to Capture; High impedance; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. SIX MONTHS AGO, THIS DEVICE REACHED AN ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT IS NOT DEPENDENT. ADDITIONALLY, INTERMITTENTLY SIGNALS OVERSENSED AND UNDERSENSED WERE OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. AN INTERROGATION WAS TRIED PERFORMED. HOWEVER; THIS DEVICE WAS UNABLE TO BE INTERROGATED. TROUBLESHOOTING EFFORTS WERE PERFORMED. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE MEASUREMENTS AND THE RA LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. LOSS OF CAPTURE WAS ALSO SEEN ON THE RA CHANNEL. LEADS REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108755 ↗
• InjuryMay 27, 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14528833 ↗
• InjuryOct 20, 2020Adverse 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. REPORTEDLY, AS PER CALL TO PATIENT ADVOCATE, THE PATIENT HAD (B)(6) INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: No Code Available; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 10708276 ↗
• InjuryMay 26, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY STATUS OF THIS PACEMAKER WAS AT ELECTIVE REPLACEMENT TIME (ERT), HOWEVER, THE DEVICE LONGEVITY REMAINING WAS LESS THAN SIX MONTHS. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THAT THE REASON LIKELY OF THE DISCREPANCY WAS THAT THE DEVICE JUST TRIPPED ERT THE SAME TIME AS THAT TRANSMISSION AND THE LONGEVITY CALCULATION HAD NOT UPDATED YET. THE TS ALSO VERIFIED THAT THERE WERE NO BRADY MODE CHANGES AT ERT BESIDES LOSING RATE RESPONSE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THA THE PACEMAKER WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 10089589 ↗
• MalfunctionApr 12, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PHYSICIAN ALLEGED THE RIGHT ATRIAL (RA) LEAD WAS BROKEN DUE TO THE PRESENCE OF NOISE ON THE RA CHANNEL. ANALYSIS BY BOSTON SCIENTIFIC TECHNICAL SUPPORT INDICATED THAT THE NOISE WAS MOST LIKELY A PRODUCT OF MYOPOTENTIALS AND/OR BACKGROUND INTERFERENCE. IT WAS RECOMMENDED THAT AT THE NEXT FOLLOW UP, LEAD INTEGRITY SHOULD BE TESTED BY PERFORMING PROVOCATIVE MANEUVERS. NO PATIENT CONSEQUENCES WERE REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509705 ↗
• MalfunctionApr 12, 2019Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEVICE WAS SHOWING BEGINNING OF LIFE (BOL) ON ITS GAS GAUGE BUT THERE SHOULD ONLY BE 1.5 YEARS REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED TO CONSIDER CONTINUED MONITORING. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 8508991 ↗
• MalfunctionJul 12, 2017Failure to Capture; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Failure to Sense; Ambient Noise Problem; Failure to Capture; Electrical /Electronic Property Problem; High impedance; Over-Sensing; Failure to Sense; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER EXHIBITED HIGH RIGHT ATRIAL (RA) IMPEDANCE MEASUREMENTS OF GREATER THAN 2500 OHMS, LOSS OF CAPTURE, NON-SENSING, NOISE, OVERSENSING AND INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. THE PATIENT WAS NOT RA LEAD DEPENDENT, AND HAD AN UNDERLYING RHYTHM IN THE 50 BEATS PER MINUTE (BPM) RANGE. THE LEAD WAS TESTED IN BIPOLAR CONFIGURATION AND SIMILAR VALUES WERE OBTAINED. THE DEVICE WAS PROGRAMMED DDD IN UNIPOLAR CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6707193 ↗
• InjuryJul 12, 2017Low impedance; Low impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED VARYING PACE IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPEDANCES WERE TYPICALLY AROUND 500 OHMS, BUT AS THE PATIENT MOVED, THE IMPEDANCES WOULD DROP TO 200 OHMS. THE RV LEAD WAS SUSPECTED TO HAVE AN INSULATION BREACH, BUT IT WAS NOT CONFIRMED. THE RV LEAD WAS SURGICALLY ABANDONED AND THE PACEMAKER WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6706313 ↗
• InjuryApr 11, 2017Failure to Capture; Failure to Capture

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THRESHOLD TESTING THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN CAPTURE WHEN PROGRAMMED TO PACE AND SENSE IN THE VENTRICLE ONLY. WHEN PROGRAMMED TO PACE AND SENSE IN BOTH CHAMBERS, CAPTURE WAS OBTAINED. IT WAS NOTED THAT THE PACEMAKER WAS PROGRAMMED TO PACE AND SENSE IN BOTH CHAMBERS AND CONTINUED TO BE PROGRAMMED THIS WAY. THIS ISSUE OCCURRED AT TWO DIFFERENT FOLLOW UP VISITS. AN X-RAY WAS TAKEN, HOWEVER THE CAUSE REMAINED UNKNOWN. AT THIS TIME THE PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6480873 ↗
• MalfunctionFeb 2, 2017Premature Discharge of Battery; Capturing Problem; Premature Discharge of Battery; Capturing Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE WAS EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6296674 ↗
• InjuryJan 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. IT WAS ALSO REPORTED THAT THE PATIENT HAD (B)(6). THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Sepsis; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 6257899 ↗
• InjuryOct 12, 2016Over-Sensing; Pacing Problem; Ambient Noise Problem; Over-Sensing; Pacing Problem; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DEPENDENT PATIENT WAS HAVING PAUSES VIA TELEMETRY. A BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS CALLED TO EVALUATE THE SYSTEM AND NO PAUSES WERE IDENTIFIED. THERE WAS SOME SLIGHT NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL ON SOME OF THE PATIENT'S ELECTROCARDIOGRAMS. ISOMETRICS AND DEVICE MANIPULATION WERE PERFORMED AND NO INHIBITION WAS OBSERVED. THE RV OUTPUT AND SENSITIVITY WERE REPROGRAMMED. LATER THAT DAY, THE PHYSICIAN AGAIN NOTED NOISE, OVERSENSING AND PACING INHIBITION WITH SOME INTERMITTENT CAPTURE. THE FOLLOWING DAY, A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LEAD. THE ASSOCIATED DEVICE WAS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PHYSICIAN WANTED TO ALSO REPLACE THE DEVICE. ACCESS TO THE LEFT SIDE COULD NOT BE OBTAINED AND A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6021228 ↗
• MalfunctionJul 14, 2016Impedance Problem; Protective Measures Problem; Impedance Problem; Protective Measures Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE BATTERY INDICATOR OF THIS PACEMAKER DISPLAYED AN ESTIMATED LONGEVITY OF 1.5 YEARS WITH A MAGNET RATE OF 90 PACING PULSES PER MINUTE DURING A SCHEDULED FOLLOW-UP. IT THEN DROPPED TO LESS THAN 6 MONTHS AFTER COMPLETING THE FOLLOW-UP EVEN THOUGH NO PROGRAMMING CHANGES WERE MADE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED HOW THE DEVICE CALCULATES THE LONGEVITY AND THE GAS GAUGE PRESENTATION. TS ALSO SUGGESTED TO HAVE THE DISK ANALYZED. DATA ANALYSIS LATER SHOWED THAT A SMALL DECREASE IN THE VENTRICULAR IMPEDANCE CAUSED THE BIN TO SWITCH THUS CAUSING THE LONGEVITY ESTIMATE TO DROP TO LESS THAN 6 MONTHS. NO INAPPROPRIATE BATTERY DEPLETION WAS NOTED. TS ADVISED TO HAVE THE DEVICE CLOSELY MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5794332 ↗