Linox Smart S 60 375012Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Linox Smart S 60 lead is a permanent defibrillator electrode implanted under the skin to deliver pacing and shock therapy. Most reports describe noise on the lead's signals, high impedance, broken or cracked lead wires, and shocks given when none were needed; some leads were capped or removed and replaced. There are 53 reports, including 1 death and 22 injuries.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 1
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 04035479116194), received between Jan 3, 2019 and Jan 29, 2024 — classified as 1 death, 22 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (20 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.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem20
- High impedance12
- Adverse Event Without Identified Device or Use Problem11
- Inappropriate/Inadequate Shock/Stimulation10
- Fracture7
- Under-Sensing4
- Impedance Problem3
- Low impedance3
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient15
- Shock from Patient Lead(s)11
- Unspecified Infection9
- Pocket Erosion2
- Chest Pain1
- Endocarditis1
- Ventricular Fibrillation1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2024Fracture; Fracture
THIS 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 18595120 ↗MalfunctionJul 25, 2023Ambient Noise Problem; Ambient Noise Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17389781 ↗MalfunctionNov 30, 2022Ambient Noise Problem; Ambient Noise Problem
RV NOISE SEEN ON HOMEMONITORING IEGMS SHOWING AFTER T WAVES. NOISE SEEMS TO BE OCCURRING MORE OFTEN. COULD NOT BE REPRODUCED IN OFFICE. WILL BE DISCUSSED FURTHER WITH PHYSICIAN ON NEXT STEPS. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15886060 ↗MalfunctionJun 8, 2022Ambient Noise Problem; Ambient Noise Problem
HMSC REPORTED NOISE RESULTING IN A VF DETECTION (SHOCK ABORTED). LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14632213 ↗MalfunctionApr 14, 2022Failure to Capture; Fracture; Impedance Problem; Failure to Capture; Fracture; Impedance Problem
PACING PORTION OF THE LEAD WAS CAPPED DUE TO MALFUNCTION. FRACTURE CAUSED OUT OF RANGE IMPEDANCE AND LOSS OF CAPTURE. ONLY IS-1 PORTION OF LEAD WAS CAPPED. 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 14116131 ↗MalfunctionMar 10, 2022Pacing Problem; Ambient Noise Problem; Device Sensing Problem; Pacing Problem; Ambient Noise Problem; Device Sensing Problem
NOISE ON RV CHANNEL REPRODUCEABLE WITH ISOMETRICS. CAPTURE AND SENSING APPEAR APPROPRIATE HOWEVER PATIENT HAS HAD EPISODES OF POTENTIAL PACING INHIBITION AND EPISODES OF LOW SENSING. 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
MAUDE report 13726766 ↗MalfunctionFeb 14, 2022Break; Break
DURING A NORMAL DEVICE CHANGE OUT, A CUT WAS FOUND IN THE INSULATION OF THIS LEAD. THE LEAD WAS CAPPED AND REPLACED. 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 13524806 ↗MalfunctionFeb 14, 2022High impedance; High impedance
HIGH SHOCK IMPEDANCES OF GREATER THAN 150 OHMS WERE REPORTED ON THIS 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 13524624 ↗MalfunctionJan 12, 2022Ambient Noise Problem; Ambient Noise Problem
THIS RV LEAD WAS EXPLANTED DUE TO NOISE. NOISE WAS ABLE TO BE RECREATED WITH POCKET MANIPULATION. 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 13239968 ↗InjuryJan 4, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
OVERSENSING AND NOISE ON THE RV LEAD, LED TO 7 INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 13154801 ↗InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12824692 ↗InjurySep 10, 2021Ambient Noise Problem; Ambient Noise Problem
LEAD EXPLANTED IN 2017 DUE TO NOISE CAUSING INAPPROPRIATE SHOCKS. LEAD WAS RETURNED TO BIOTRONIK FOR ANALYSIS ON 16-AUG-2021. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE
Patient problems: Shock from Patient Lead(s)
MAUDE report 12454518 ↗InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Endocarditis
MAUDE report 12436373 ↗InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12099174 ↗MalfunctionJun 30, 2021Fracture; Low impedance; Ambient Noise Problem; Fracture; Low impedance; Ambient Noise Problem
IT WAS REPORTED THAT THIS LEAD WAS CAPPED DUE TO FRACTURE CAUSING NOISE ON THE RV CHANNEL. A DECREASE IN SHOCK IMPEDANCE WAS ALSO NOTICED AT THE BEGINNING OF JUNE 2021. 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 12096344 ↗InjuryJun 4, 2021Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
RV LEAD WAS CAPPED DUE TO NOISE. INAPPROPRIATE SHOCK DELIVERED AND PACING INHIBITED DUE TO PACER DEPENDENCY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 11942700 ↗DeathMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD CAPPED DUE TO INFECTION WITH EROSION. DEVICE AND RA LEAD EXTRACTED. LV AND RV CAPPED. PATIENT EXPIRED ON THE SAME DAY AS THE PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 11892981 ↗MalfunctionApr 21, 2021High impedance; High impedance
PER CLINICIAN, SHOCK IMPEDANCE INCREASING IN THE PAST FEW DAYS. ADVISED TO EVALUATE LEAD FURTHER. LEAD CURRENTLY 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 11700944 ↗InjuryMar 10, 2021Adverse 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 11455887 ↗InjuryFeb 22, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THIS LEAD WAS CAPPED AND REPLACED DUE TO 20 INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 11361235 ↗InjuryFeb 18, 2021Ambient Noise Problem; Ambient Noise Problem
THIS RV LEAD WAS EXPLANTED AND REPLACED DUE TO NOISE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions
MAUDE report 11345948 ↗InjuryJan 4, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11112652 ↗InjuryDec 15, 2020Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Fracture; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS LEAD WAS CAPPED AND REPLACED DUE TO MULTIPLE SHOCKS FROM NOISE. PHYSICIAN SUSPECTED FRACTURE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 11015299 ↗MalfunctionDec 4, 2020High impedance; High impedance
INTERMITTENT OUT OF RANGE SHOCK IMPEDANCE WAS REPORTED ON THIS LEAD (GREATER THAN 150 OHMS), BEGINNING IN (B)(6) OF 2020. OUT OF RANGE MEASUREMENTS COULD NOT BE REPRODUCED WITH POSTURAL TESTING AND POCKET MANIPULATION IN OFFICE. 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 10945395 ↗MalfunctionNov 24, 2020Over-Sensing; Under-Sensing; Low impedance; Over-Sensing; Under-Sensing; Low impedance
DEVICE WAS CAPPED DUE TO UNDERSENSING, OVERSENSING, AND LOW IMPEDANCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10891736 ↗
Other Permanent defibrillator electrodes devices
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes333 deaths30,581 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M62Medtronic, Inc. · Permanent defibrillator electrodes221 deaths14,405 reports
- Capsurefix® Novus 5076-52Medtronic, Inc. · Permanent defibrillator electrodes111 deaths9,860 reports
- CapSureFix Novus MRI™ SureScan® 5076-52Medtronic, Inc. · Permanent defibrillator electrodes80 deaths8,280 reports
- Sprint Quattro Secure S MRI™ SureScan™ 6935M55Medtronic, Inc. · Permanent defibrillator electrodes116 deaths7,750 reports
- Durata™ 7122Q-58St. Jude Medical, Inc. · Permanent defibrillator electrodes151 deaths6,202 reports
- Durata™ 7122Q-65St. Jude Medical, Inc. · Permanent defibrillator electrodes86 deaths4,773 reports
- Capsurefix® Novus 5076-58Medtronic, Inc. · Permanent defibrillator electrodes47 deaths4,587 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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