Intica Neo 5 DR-T DF-1 ProMRI 429568Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035479156947), received between Oct 29, 2020 and May 28, 2021 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE WAS PROPHYLACTICALLY EXCHANGED APPROX. 10 MONTHS AFTER THE IMPLANTATION. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904975 ↗
• MalfunctionMay 13, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE RV LEAD (LINOX SMART SD) WAS CAPPED DUE TO LOW SHOCK IMPEDANCE MEASUREMENTS APPROX. 109 MONTHS AFTER THE IMPLANTATION. DURING THE REVISION SURGERY THE ASSOCIATED ICD WAS PROPHYLACTICALLY EXCHANGED AFTER 9 MONTHS OF IMPLANTATION PERIOD. THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN MARCH 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819384 ↗
• MalfunctionDec 12, 2020Failure to Capture; Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Failure to Capture; Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED, THAT APPROXIMATELY 15 DAYS AFTER IMPLANTATION TIME, APPROPRIATE BUT INEFFECTIVE SHOCKS WERE DELIVERED BY THE IMPLANTED ICD AND AN EXTERNAL SHOCK WAS DELIVERED BY THE EMERGENCY DOCTOR. THE DEVICE COULD NO LONGER BE QUERIED AND IS FUNCTIONALLY INEFFECTIVE (NO MORE VENTRICULAR STIMULATION IN THE CASE OF (B)(6)). ON (B)(6) 2020 THE ICD DELIVERED MULTIPLE SHOCKS, BUT THESE WERE NOT EFFECTIVE. THE EMERGENCY DOCTOR FOUND VENTRICULAR FIBRILLATION AND SHOCKED THE PATIENT EXTERNALLY SEVERAL TIMES. THIS ENABLED THE PATIENT TO BE BROUGHT INTO A NORMAL-FREQUENCY HEART RHYTHM. THE PATIENT WAS ADMITTED TO THE (B)(6) HOSPITAL AND GIVEN AN ECMO DUE TO HIS POOR CONDITION. LATER THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND REMAINS IN THE INTENSIVE CARE UNIT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 10996472 ↗
• MalfunctionDec 12, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  AFTER AN IMPLANTATION PERIOD OF APPROX. 3 MONTHS, IT WAS OBSERVED THAT THE DEVICE SHOWS THE ERI STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10996432 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER AN IMPLANTATION PERIOD OF APPROX. 10 MONTHS, AN ASYSTOLE WAS OBSERVED.

  Patient problems: Asystole

  MAUDE report 10758808 ↗