Linox Smart SD 65/16 359066Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04035479100391), received between Mar 18, 2019 and Jul 2, 2026 — classified as 1 death, 22 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (24 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026High impedance

  INTERMITTENT OUT OF RANGE SHOCK IMPEDANCE (GREATER THAN 150 OHMS) SEEN ON FOLLOW-UP TRENDS FROM DEC-2025. POSTURAL TESTING IN OFFICE WAS UNREMARKABLE. LEAD IS CURRENTLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696595 ↗
• MalfunctionJul 5, 2022High impedance; High impedance

  LEAD WAS CAPPED DUE TO HIGH SHOCK IMPEDANCES. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917903 ↗
• MalfunctionJul 1, 2022Fracture; Fracture

  THIS LEAD WAS CAPPED DUE TO FRACTURE BY HEADER 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 14885834 ↗
• MalfunctionJun 29, 2022Impedance Problem; Impedance Problem

  LEAD WAS CAPPED DUE TO AN OUT OF RANGE OF VOLTAGE AND PACING IMPEDANCE. 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 14862495 ↗
• DeathJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM RECURRENT FALL. THE PATIENT WAS HOSPITALIZED. BLOOD TEST AND BLOOD CULTURES WERE DONE. (B)(6) INFECTION WAS SEEN IN THE BLOOD CULTURES. THE DEVICE WAS REPROGRAMMED (DEACTIVATED) AND REMAINS IMPLANTED. THE PATIENT DIED IN THE HOSPITAL. MULTIORGAN FAILURE DUE TO SEPSIS HAS BEEN PROVIDED AS A CAUSE OF DEATH.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14804334 ↗
• MalfunctionJun 6, 2022High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  PACING IMPEDANCE IS GREATER THAN 3000 AND NOISE WAS NOTED. 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 14605205 ↗
• MalfunctionMay 13, 2022Fracture; Fracture

  RV LEAD WAS EXPLANTED DUE TO FRACTURE. 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 14401350 ↗
• MalfunctionApr 29, 2022Ambient Noise Problem; Ambient Noise Problem

  NOISE WAS REPORTED ON THE LEAD. LEAD WAS EXPLANTED. 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 14254941 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 14218747 ↗
• MalfunctionApr 22, 2022Over-Sensing; Device Dislodged or Dislocated; Over-Sensing; Device Dislodged or Dislocated

  THIS LEAD WAS EXPLANTED DUE TO LEAD PULLED BACK FROM DEVICE MIGRATION AS A RESULT OF WEIGHT LOSS. LEAD WAS ALSO OVERSENSING. 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 14188250 ↗
• MalfunctionApr 12, 2022Ambient Noise Problem; Ambient Noise Problem

  THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO NOISE. THE SHOCKING PORTION OF THE LEAD REMAINS ACTIVELY 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 14089076 ↗
• MalfunctionMar 23, 2022Ambient Noise Problem; Ambient Noise Problem

  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 13871119 ↗
• MalfunctionFeb 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS RV LEAD WAS CAPPED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600222 ↗
• MalfunctionFeb 22, 2022Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT OVERSENSING WITH ARTIFACTS WAS NOTED ON RV CHANNEL APPROX. 131 MONTHS AFTER THE IMPLANTATION. THIS LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. 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 13578054 ↗
• MalfunctionFeb 21, 2022Break; Break

  THE FIRST COMPLAINT INFORMATION WAS RECEIVED ON (B)(6) 2022. AFTER UPDATE RECEIVED ON (B)(6)2022 THE LEAD WAS IDENTIFIED AND IT WAS DECIDED TO REPORT THE EVENT ASSOCIATED WITH IT.AFTER AN ESTIMATED IMPLANTATION PERIOD OF APPROX. 99 MONTHS, IT WAS OBSERVED THAT THE SVC COIL OF THE LEAD IS DAMAGED. THE ICD WAS RE-PROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573248 ↗
• InjuryJan 31, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  AFTER AN IMPLANTATION PERIOD OF APPROX. 116 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13404728 ↗
• InjuryJan 11, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO OVERSENSING WITH INAPPROPRIATE SHOCKS APPROX. 139 MONTHS AFTER THE IMPLANTATION.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13226103 ↗
• MalfunctionNov 16, 2021Ambient Noise Problem; Ambient Noise Problem

  LEAD EXPLANTED DUE TO FAILURE AND LEAD NOISE. 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 12824660 ↗
• MalfunctionNov 9, 2021High impedance; High impedance

  AFTER AN IMPLANTATION PERIOD OF APPROX. 134 MONTHS, IT WAS OBSERVED THAT THE SHOCK IMPEDANCE WAS TOO HIGH. THE LEAD WAS CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780082 ↗
• MalfunctionOct 20, 2021Failure to Capture; High impedance; Failure to Capture; High impedance

  LEAD EXPLANTED DUE TO HIGH RV PACE/SENSE IMPEDANCE OF 2900 OHMS. FAILURE TO CAPTURE AT MAX OUTPUT. 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 12667247 ↗
• MalfunctionOct 19, 2021Ambient Noise Problem; Ambient Noise Problem

  LEAD CAPPED DUE TO NOISE. 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 12661340 ↗
• MalfunctionOct 14, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  LEAD CAPPED DUE TO DISLODGEMENT AND INSULATION FAILURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634799 ↗
• MalfunctionOct 13, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO RV IMPEDANCE GREATER THAN 3000. 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 12623571 ↗
• MalfunctionSep 28, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 105 MONTHS, IT WAS REPORTED THAT OVERSENSING IN THE VENTRICULAR CHANNEL WAS DETECTED. THE LEAD REPLACEMENT IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541236 ↗
• InjurySep 27, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 123 MONTHS, IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO OVERSENSING IN THE VENTRICULAR CHANNEL. THE LEAD WAS EXTRACTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12533844 ↗