Evia DR 359524Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04035479101299), received between Jul 12, 2019 and Mar 2, 2022 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THIS DEVICE SHOWS ERI AND A BATTERY ERROR MESSAGE. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13657058 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PACEMAKER WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 12916833 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Unspecified Infection

  MAUDE report 12356605 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE EXPLANTED DUE TO SYSTEMIC INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: Unspecified Infection

  MAUDE report 12025093 ↗
• MalfunctionMay 27, 2021Premature Elective Replacement Indicator; No Pacing; Premature Elective Replacement Indicator; No Pacing

  RECEIVED MEDWATCH REPORT MW5100931. DEVICE REPORTED ERI AND LOST PACING FUNCTION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892977 ↗
• MalfunctionMar 29, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO EOS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11583053 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROX. 1 MONTHS AFTER THE IMPLANTATION THE PATIENT HAD CAPSULAR INFECTION AND WAS ADMITTED TO THE HOSPITAL. DEBRIDEMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED. THE PATIENT CAME TO THE HOSPITAL FOR A REEXAMINATION ON (B)(6) 2020. THE PATIENT WAS FOUND TO HAVE INFECTION OF THE CAPSULE AGAIN, AND THE CAPSULE RUPTURED, WHICH WAS TREATED IN THE HOSPITAL. THE REPLACEMENT OPERATION IS UNDER PLANNING.

  Patient problems: Unspecified Infection

  MAUDE report 11152305 ↗
• MalfunctionOct 15, 2020High impedance; High impedance

  DEVICE WAS REMOVED DUE TO HIGH IMPEDANCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683548 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 10279742 ↗
• InjuryDec 5, 2019High impedance; High impedance

  AFTER 2 YEARS, THE IMPEDANCE OF THE RV LEAD CONTINUED TO INCREASE, AND THE PATIENT EXPERIENCED SYNCOPE A FEW TIMES.

  Patient problems: Syncope

  MAUDE report 9416573 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE FOLLOW UP ON (B)(6) 2018, IT WAS NOTED THE POCKET WAS RUPTURED AND INFECTED. THE DEVICE WAS REMOVED AND THE LEADS WERE CAPPED IN THE PATIENT BODY.

  Patient problems: Rupture; Unspecified Infection

  MAUDE report 8787167 ↗