Linox Smart TD 65/18 359074Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04035479100476), received between Mar 20, 2019 and Apr 3, 2024 — classified as 1 death, 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2024High impedance; High impedance

  THIS LEAD WAS CAPPED DUE TO HIGH PACING IMPEDANCES OF GREATER THAN 3000 OHMS. 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 19038460 ↗
• MalfunctionAug 24, 2023Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  RV PACE/SENSE PORTION IS CAPPED DUE TO OUT OF RANGE IMPEDANCE AND NO CAPTURE. 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 17619340 ↗
• MalfunctionFeb 21, 2022Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED DUE TO INCREASING THRESHOLD AND IMPEDANCE AFTER THE IMPLANTATION PERIOD OF APPROX. 141 MONTHS. 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 13569993 ↗
• MalfunctionSep 28, 2021High impedance; Device Sensing Problem; High impedance; Device Sensing Problem

  LEAD WAS CAPPED DUE TO INAPPROPRIATE SENSING, DIMINISHED R WAVES, AND HV IMPEDANCE INTERMITTENTLY GREATER THAN 150 OHMS. 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 12539688 ↗
• MalfunctionJun 16, 2021High impedance; High impedance

  LEAD REMAINS IMPLANTED. PER CLINICIAN DEVICE REPORTED OUT OF RANGE SHOCK IMPEDANCE GREATER THAN 200 OHMS. SHOCK PATHWAY WAS RE-PROGRAMMED WITHOUT THE SVC COIL. INOFFICE EVALUATION SHOWED OUT OF RANGE SHOCK IMPEDANCE. ALL OTHER MEASUREMENTS WERE UNREMARKABLE. NO POSTURAL TESTING PERFORMED. DATA TO BE PRESENTED TO PHYSICIAN FOR NEXT STEPS. 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 12010538 ↗
• MalfunctionMay 13, 2021High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  SHOCK IMPEDANCE GREATER THAN 150 OHMS WAS REPORTED ON THIS RV LEAD. POSSIBLE NOISE ON FF CHANNEL. LEAD REMAINS IMPLANTED. 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 11822108 ↗
• InjuryApr 21, 2021Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Impedance Problem

  APPARENT NOISE ON RV LEAD. FULL LEAD EVALUATION RECOMMENDED. LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 11704142 ↗
• MalfunctionOct 9, 2020Ambient Noise Problem; Ambient Noise Problem

  (B)(6) 2020, THERE WAS AN ALERT RECEIVED DUE TO LEAD NOISE VIA HM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10658511 ↗
• MalfunctionOct 2, 2020Ambient Noise Problem; Ambient Noise Problem

  THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO NOISE. 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 10623629 ↗
• DeathSep 25, 2020Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROX. 100 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. DURING THE EXTRACTION OF THE LEAD AFTER CUTTING THE PROXIMAL COIL, THE VENA CAVA RUPTURED AND THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 10589654 ↗
• MalfunctionAug 21, 2020Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS LEAD WAS FRACTURED WITH RISING IMPEDANCES SINCE (B)(6) 2020. LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. LEAD WAS RETURNED (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10439539 ↗
• MalfunctionApr 20, 2020Fracture; High impedance; Fracture; High impedance

  AFTER AN IMPLANTATION PERIOD OF APPROX. 85 MONTHS, IT WAS REPORTED THAT THE SHOCK IMPEDANCE WAS TOO HIGH. DURING THE ICD-SYSTEM REVISION IT WAS OBSERVED THAT THE LEAD WAS FRACTURED PROXIMAL TO THE CONNECTOR. THE LEAD WAS CAPPED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9979520 ↗
• MalfunctionNov 21, 2019Ambient Noise Problem; Ambient Noise Problem

  APPARENT NOISE ON RV INTRACARDIAC AS WELL AS INTERMITTENT FF NOISE. LEAD REMAINS IMPLANTED. 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 9357019 ↗
• MalfunctionSep 26, 2019High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED AND REPLACED DUE TO THRESHOLD AT MAX OUTPUT. 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 9126633 ↗
• InjurySep 19, 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 BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9087165 ↗
• MalfunctionApr 23, 2019Ambient Noise Problem; Ambient Noise Problem

  NOISE WAS OBSERVED ON THIS LEAD. P/S PORTION OF THE LEAD WAS CAPPED AND A NEW LEAD WAS PLACED. 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 8542326 ↗
• MalfunctionMar 20, 2019High impedance; High impedance

  THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH IMPEDANCES. 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 8438497 ↗