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Linox Smart S 75 369819Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04035479112981), received between Jun 7, 2019 and Jul 1, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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

Device problems

  • Fracture3
  • Ambient Noise Problem2
  • High Capture Threshold2
  • Adverse Event Without Identified Device or Use Problem1
  • Device Sensing Problem1
  • Inappropriate/Inadequate Shock/Stimulation1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions1
  • Occlusion1
  • Shock from Patient Lead(s)1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 1, 2021Fracture; Inappropriate/Inadequate Shock/Stimulation; Fracture; Inappropriate/Inadequate Shock/Stimulation

    LEAD CAPPED DUE TO FRACTURE CAUSING INAPPROPRIATE SHOCKS. ULTIMATELY DOWNGRADED TO CRTP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

    Patient problems: Shock from Patient Lead(s)

    MAUDE report 12099186 ↗
  • MalfunctionOct 28, 2020Fracture; Device Sensing Problem; High Capture Threshold; Fracture; Device Sensing Problem; High Capture Threshold

    THIS LEAD HAD HIGH THRESHOLDS AND SENSING ISSUES. THERE WAS A POSSIBLE FRACTURE. THE LEAD WAS CAPPED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10748877 ↗
  • InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO VASCULAR OCCLUSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Patient problems: Occlusion

    MAUDE report 10393719 ↗
  • MalfunctionMay 27, 2020High Capture Threshold; High Capture Threshold

    THIS LEAD WAS EXPLANTED DUE TO 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 10094192 ↗
  • MalfunctionJun 19, 2019Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem

    THIS LEAD WAS CAPPED DUE TO LEAD FRACTURE AND NOISE. 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 8712229 ↗
  • MalfunctionJun 7, 2019Ambient Noise Problem; Ambient Noise Problem

    NOISE WAS DETECTED ON THIS RV LEAD. LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8680938 ↗

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Sources and updates

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