NA 5866-24MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00681490136785), received between Oct 16, 2018 and Aug 24, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Signal Artifact/Noise” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE AND A PREVIOUSLY CAPPED ADAPTOR WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17610693 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST IMPLANT OF THE RIGHT ATRIAL (RA) LEAD THAT THE PATIENT EXPERIENCED AN INFECTION. ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15769859 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST IMPLANT OF THE RIGHT ATRIAL (RA) LEAD THAT THE PATIENT EXPERIENCED AN INFECTION. ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15769840 ↗
• MalfunctionOct 16, 2018Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PACING LEAD WAS EXHIBITING NOISE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7970093 ↗