Evity 6 DR-T 407149Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04035479147686), received between Jul 18, 2019 and Mar 17, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Pacemaker Found in Back-Up Mode; Unexpected Mode Switch; Pacemaker Found in Back-Up Mode; Unexpected Mode Switch

  AT FIRST INTERROGATION THE PROGRAMMER SHOWED THAT THE DEVICE WAS IN SAFE MODE. WE PRESSED THE RE-INITIALIZE BUTTON AND THE DEVICE SWITCH TO NORMAL WINDOW BUT WITH RF TELEMETRY DISABLED, SO WE DECIDED TO RETURN THE DEVICE FOR FURTHER INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794547 ↗
• MalfunctionNov 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BEFORE IMPLANT, THE PACEMAKER WAS INTERROGATED, PRESENTING ERROR MESSAGE AND BEING ASKED TO BE REINITIALIZED. REINITIALIZATION WAS PERFORMED BUT RESULTED UNSUCCESSFUL, SINCE THE PACEMAKER CONTINUES WITH THE ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868544 ↗
• MalfunctionJun 4, 2021Failure to Capture; Failure to Capture

  ON THE EVENT DATE, THE FIELD REP WAS CONTACTED TO PROVIDE SUPPORT TO A DOCTOR AND EVALUATE A PACEMAKER PATIENT THAT WAS AT 28BPM. WHEN INTERROGATED, THE DEVICE SHOWED THE MESSAGE TO PERFORM MEMORY DUMP AND TO CALL BIOTRONIK. BOTH LEADS WERE EVALUATED, PROVIDING LESS THAN 100 OHMS IMPEDANCE (UNIPOLAR OR BIPOLAR), NO CAPTURE (A OR V), SUGGESTING LEADS FRACTURE.

  Patient problems: Bradycardia

  MAUDE report 11942987 ↗
• MalfunctionMay 25, 2021Failure to Interrogate; Failure to Interrogate

  AFTER AN IMPLANTATION PERIOD OF APPROX. 19 MONTHS, IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED BY TWO (2) DIFFERENT PROGRAMMERS. THE PACEMAKER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874309 ↗
• MalfunctionOct 9, 2020Failure to Capture; Failure to Capture

  SIX HOURS AFTER IMPLANTATION, IT WAS OBSERVED THE PACEMAKER PRESENTED LOSS OF CAPTURE. THE PHYSICIAN REOPENED THE PATIENT AND REPOSITIONED THE LEAD. THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10658465 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DEVICE WAS EXPLANTED DUE TO INFECTION AT THE WOUND SITE. THE WOUND EDGES DID NOT HEAL, PHYSICIAN HAS BEEN TREATING PATIENT WITH ANTIBIOTICS AND SUSPECTS A FISTULA.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 9779847 ↗
• MalfunctionSep 25, 2019Premature End-of-Life Indicator; Premature End-of-Life Indicator

  THIS DEVICE WAS EXPLANTED DUE TO EOS. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119694 ↗
• MalfunctionJul 18, 2019Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem

  IT WAS REPORTED THAT OVERSENSING OCCURRED APPROXIMATELY 1 MONTHS AFTER THE IMPLANTATION.

  Patient problems: Fall; No Known Impact Or Consequence To Patient; Syncope

  MAUDE report 8804687 ↗