ALTRUA™ 2 EL DR S722Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00802526559365), received between Apr 29, 2019 and Apr 6, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryApr 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS DEVICE PRESENTED TO THE EMERGENCY ROOM FEELING UNEASY. UPON INTERROGATION IT WAS IDENTIFIED THE DEVICE WAS OPERATING IN SAFETY MODE. NEW INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS EXPLANTED AND WILL BE RETURNED FOR EVALUATION.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 14032489 ↗
• InjuryJan 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER WAS SUSPECTED TO BE EXHIBITING PREMATURE BATTERY DEPLETION. A SAVE TO DISK WAS SENT IN FOR ENGINEERING ANALYSIS AND IT WAS CONFIRMED THAT THERE WAS AN INCREASE IN POWER CONSUMPTION. BOSTON SCIENTIFIC TECHNICAL SERVICES RECOMMENDED DEVICE REPLACEMENT BECAUSE OF THIS ANOMALY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13329640 ↗
• InjuryJan 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPERIENCED AN INFECTION. THIS PACEMAKER WAS EXPLANTED AND REPLACED WITH A NEW ONE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE IS EXPECTED FOR RETURN.

  Patient problems: Unspecified Infection

  MAUDE report 13139212 ↗
• InjuryApr 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A POST IMPLANT INTERROGATION, THREE DEVICE RESETS WERE EXHIBITED AND THE DEVICE CONSEQUENTLY IN SAFETY MODE. TECHNICAL SERVICES (TS) WAS CALLED TO PROVIDE GUIDANCE REGARDING THE OPERATION OF THIS UNEXPECTED PROGRAMING OPERATION. TS STATED THAT ONCE IN SAFETY MODE, THE DEVICE WOULD NEED TO BE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED AND REPLACEMENT LATER THAT SAME DAY WAS CONFIRMED. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS. ANOTHER DEVICE OF SAME MODEL TYPE WAS IMPLANTED WITHOUT FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668826 ↗
• MalfunctionApr 29, 2019Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THIS PACEMAKER WAS CONNECTED TO THE LEADS HOWEVER THE FIELD WAS UNABLE TO ESTABLISH TELEMETRY AND INTERROGATE IT. DESPITE TROUBLESHOOTING, THE PHYSICIAN COULD NOT RESOLVE THE ISSUE SO THE PACEMAKER WAS REMOVED AND REPLACED PRIOR TO POCKET CLOSURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562894 ↗