Acticor 7 DR-T DF4 ProMRI 429524Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04035479156695), received between Dec 20, 2019 and Jun 3, 2022 — classified as 1 death, 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14597614 ↗
• MalfunctionMay 26, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  HIGH SHOCK IMPEDANCE OBSERVED ON THE RV LEAD. DOCTOR DECIDED TO EXPLANT AND REPLACE DEVICE AT SAME TIME AS LEAD. 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 14515591 ↗
• MalfunctionFeb 7, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator

  AFTER AN IMPLANTATION PERIOD OF APPROX. 16 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE EOS STATUS. THE ICD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477014 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER ICD IMPLANT (DURING HOSPITALIZATION), IT WAS SWOLLEN, AND IT WAS DEEMED INFECTION AFTER BLOOD TEST. ALL THE SYSTEM WAS REMOVED FROM THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 13471763 ↗
• DeathDec 1, 2021Failure to Interrogate; Failure to Interrogate

  AFTER AN IMPLANTATION PERIOD OF APPROX. 19 MONTHS, IT WAS REPORTED THAT THE INTERROGATION OF THE DEVICE WAS NOT SUCCESSFUL. THE PATIENT DIED SIX DAYS AFTER THE INCIDENT AND THE ICD WAS EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12913951 ↗
• MalfunctionNov 3, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 7 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. CONSULTATION IS NOW TAKING PLACE BETWEEN THE PHYSICIAN AND PATIENT TO EXPLANT THE WHOLE SYSTEM FOR A COMPLETELY NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745690 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SYSTEM WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12636300 ↗
• InjuryAug 18, 2021High impedance; Migration or Expulsion of Device; High impedance; Migration or Expulsion of Device

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO POCKET EROSION.

  Patient problems: Pocket Erosion

  MAUDE report 12336215 ↗
• MalfunctionMay 7, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED THAT NOISE WAS DETECTED ON THIS PATIENTS RV LEAD. PHYSICIANS WERE UNABLE TO DETERMINE IF THE NOISE WAS DUE TO THE LEAD OR THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2021 AND THE LEAD WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790381 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A CORONARY BYPASS SURGERY. DUE TO SUSPECT OF INFECTION BY THE SURGERY, BECAUSE THE PATIENT HAD A FEVER FOR 37C, AND REDDISH COLOR AT THE POCKET AREA SKIN, THIS DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11087737 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT VISITED TO THE HOSPITAL FOR REGULAR CHECK UP. IT WAS NOTED THAT THE POCKET AREA WAS REDDISH AND SWOLLEN. THE PATIENT WAS DIAGNOSED WITH AN INFECTION AND THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9964815 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THAT THERE WAS REDNESS AND SWELLING AT THE POCKET AREA. THE ACTICOR AND LEADS WERE ALL REMOVED DUE TO POSSIBILITY OF INFECTION.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 9866864 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD BLEEDING AND A HEMATOMA DUE TO CONTINUOUS USE OF DIRECT ORAL ANTICOAGULANTS. THE PHYSICIAN DIAGNOSED THE PATIENT WITH A POCKET INFECTION.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 9623981 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A FEVER AND BACILLAEMIA WAS REPORTED. SUSPECTED POCKET INFECTION WAS OBSERVED.

  Patient problems: Bacterial Infection; Fever

  MAUDE report 9577223 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FOUND THAT THE ICD WAS EXPLANTED DUE TO INFECTION. THE ENTIRE ICD SYSTEM WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9506171 ↗