Etrinsa 8 HF-T 394919Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04035479131777), received between Jul 2, 2018 and Mar 30, 2026 — classified as 1 death, 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse 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 24722126 ↗
• MalfunctionMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE EXPLANTED DUE TO ERI. PATIENT PRESENTED TO ER ON (B)(6) 2025 AND AT INTERROGATION, DEVICE HAD NO RESPONSE TO MAGNET. NO RECENT PROCEDURES OR EVENTS REPORTED. 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 21986094 ↗
• InjuryMay 6, 2024Ambient Noise Problem; Ambient Noise Problem

  WHILE NURSE WAS CHANGING DRESSING, PATIENT PASSED OUT AND HAD NO PULSE, THEN WOKE UP ON THEIR OWN WITH PULSE AROUND 40BPM (PACEMAKER PROGRAMMED TO 60BPM). EMT ALSO REPORTED 40BPM PULSE. HMSC SHOWS NO UNUSUAL BEHAVIOR OR EPISODES ON THAT DAY. PACING PERCENTAGE ON THAT DAY REPORTED 100 PERCENT. DISCUSSED POSSIBILITIES OF NOISE FROM LEAD OR EXTERNAL EMI INTERFERING WITH DEVICE. RECOMMENDED DEVICE EVALUATION WITH ISOMETRIC TESTING. DEVICE REMAINS IMPLANTED.

  Patient problems: Bradycardia; Loss of consciousness

  MAUDE report 19255993 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE WAS EXPLANTED DUE TO SITE PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: Implant Pain

  MAUDE report 18700024 ↗
• InjurySep 8, 2022Adverse 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, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 15379402 ↗
• MalfunctionJun 2, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DEVICE EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925350 ↗
• MalfunctionJan 25, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THIS DEVICE IS AT ERI. THE OUTPUTS ARE PROGRAMMED HIGH WHICH IS WHAT PROBABLY CAUSED THE EARLY ERI. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227656 ↗
• InjurySep 10, 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 10518564 ↗
• MalfunctionApr 20, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THIS DEVICE WAS EXPLANTED DUE TO ERI. HIGH THRESHOLDS ON LV LEAD MAY HAVE CONTRIBUTED TO BATTERY DEPLETION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9979788 ↗
• MalfunctionFeb 19, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DEVICE EXPLANTED DUE TO ERI, WHICH WAS REACHED DUE TO HIGH LV THRESHOLD AND THE RV LEAD NOT BEING OPTIMIZED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9730069 ↗
• 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 (B)(6) 2020. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9599332 ↗
• MalfunctionDec 19, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  DEVICE REACHED ERI EARLY DUE TO VERY HIGH PROGRAMMED OUTPUTS AND PULSE WIDTHS. THE PATIENT HAS EPICARDIAL LEADS WITH HIGH THRESHOLDS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497646 ↗
• MalfunctionOct 14, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI FROM LV LEAD WITH HIGH THRESHOLDS AND IS PROGRAMMED TO 6.5V AT 1.0MS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9187387 ↗
• MalfunctionSep 11, 2019Difficult to Interrogate; Difficult to Interrogate

  CLINIC IS HAVING DIFFICULTY INTERROGATING THE DEVICE. DEVICE TO BE EVALUATED FURTHER. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8992367 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT HAS SINCE RECOVERED WITHOUT SEQUELA. THE LEADS HAVE NOT BEEN RETURNED AT THIS TIME. 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 8261024 ↗
• MalfunctionNov 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI AFTER 17 MONTHS. THE LV OUTPUT WAS PROGRAMMED AT 1.5MS WHICH CAUSED BATTERY DEPLETION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053301 ↗
• InjuryOct 23, 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 7995913 ↗
• DeathSep 19, 2018Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYNCOPE, DIZZINESS AND HR IN THE (B)(6). THE EKG ON ARRIVAL SHOWED FAILURE TO CAPTURE. PATIENT WAS GIVEN MULTIPLE DOSES OF ATROPHINE WITH NO SUCCESS AND EXTERNALLY PACED. THE CATH LAB WAS BEING PREPARED WITH A TEMPORARY PACER HOWEVER PATIENT ARRESTED AND CODED FOR AN HOUR. PATIENT WAS GIVEN EPINEPHRINE AS WELL AS BEING INTUBATED. LAB RESULTS FOUND PATIENT TO BE IN RENAL FAILURE WITH A CREATININE OF 7.3 AND A POTASSIUM OF 7.0 NOTED AS LIKELY THE CAUSE OF THE PATIENTS ARRHYTHMIA. PATIENT RECEIVED GLUCONATE HOWEVER WAS STILL UNRESPONSIVE. PATIENTS BLOOD PRESSURE KEPT DECREASING AND WHEN THEY COULD NOT FEEL A PULSE, CPR WAS STARTED AND UNSUCCESSFUL. PATIENT EXPIRED. PHYSICIANS FINAL REPORT STATED ACIDOSIS/HYPERKALEMIA AND RENAL FAILURE AS CAUSE OF DEATH. THE DEATH CERTIFICATE SHOWS COMPLICATIONS OF EXISTING MEDICAL CONDITIONS AS CAUSE OF DEATH.

  Patient problems: Death; Dizziness; Syncope

  MAUDE report 7889037 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CRT-P SYSTEM WAS REMOVED DUE TO INFECTION. A NEW SYSTEM WAS PLACED THE SAME DAY.

  Patient problems: Unspecified Infection

  MAUDE report 7725971 ↗
• MalfunctionJul 2, 2018Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI 20 MONTHS AFTER IMPLANTATION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7656949 ↗