Eluna 8 SR-T ProMRI 394971Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04035479131951), received between Jul 18, 2018 and Oct 18, 2023 — classified as 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Failure to Interrogate; Failure to Interrogate

  DEVICE COULD NOT BE INTERROGATED. NO ADVERSE PATIENT EVENTS WERE REPORTED. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961510 ↗
• MalfunctionMay 13, 2022Battery Problem; Battery Problem

  AFTER AN IMPLANTATION PERIOD OF APPROX. 82 MONTHS, AN UNEXPECTED DECREASE OF THE REMAINING BATTERY CHARGE WAS OBSERVED DURING THE LAST FOLLOW UPS. THE PACEMAKER WAS EXPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401245 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 13042275 ↗
• MalfunctionFeb 18, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  AFTER AN IMPLANTATION PERIOD OF APPROX. 65 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. THE REPLACEMENT OF THE PACEMAKER IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346007 ↗
• MalfunctionNov 20, 2020Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  AFTER AN IMPLANTATION PERIOD OF APPROX. 37 MONTHS, THE TECHNICIAN OBSERVED THAT THE DEVICE IS IN BACK-UP MODE. THE DEVICE WAS EXPLANTED. BASED ON ANALYSIS RESULTS IT WAS DECIDED TO REPORT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10880166 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS REMOVED DUE TO AN INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 10787026 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10203615 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 10140931 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9955046 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. FACILITY RETAINS ITEMS EXPLANTED FOR INFECTION; PRODUCT RETURN IS NOT CURRENTLY ANTICIPATED.

  Patient problems: Unspecified Infection

  MAUDE report 9597198 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED (B)(6) 2019. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9553114 ↗
• MalfunctionOct 16, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  ERI STATUS HAS BEEN FOUND AT THE HOSPITAL, AND IT HAS BEEN AT ERI SINCE (B)(6) 2019. THE LAST FOLLOW UP WAS (B)(6) 2018 WITHOUT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9199510 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, DEVICE WAS MOVED FROM LEFT SIDE TO RIGHT SIDE DURING A LEAD REVISION. ON (B)(6) 2019, DEVICE WAS EXPLANTED AND REPLACED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 8928094 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED SAME DAY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 8876674 ↗
• MalfunctionMay 9, 2019Battery Problem; Battery Problem

  DEVICE WAS ERI AT FOLLOW-UP. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595438 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 8353946 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED (B)(6) 2018. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 7862084 ↗
• InjuryAug 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 7775775 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 7737156 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS REMOVED DUE TO INFECTION. THERE IS NO INDICATION OF A NEW SYSTEM BEING IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7702948 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SYSTEM WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7698172 ↗