Linox Smart S 65 369818Recalls & 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 defibrillator lead is an implanted wire that connects a heart defibrillator to the heart. The 238 reports mostly describe electrical noise on the lead, unwanted shocks and fractures, and some describe the lead being turned off or removed after infections. The reports include 75 injuries and no deaths. No recalls name this device. The reports fell to 5 in the last 12 months from 9 in the 12 months before.
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
- 237
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 04035479112974), received between Sep 10, 2018 and Jun 9, 2026 — classified as 74 injuries, 163 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (76 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 Problem76
- Inappropriate/Inadequate Shock/Stimulation45
- Over-Sensing43
- High impedance38
- Fracture36
- Adverse Event Without Identified Device or Use Problem27
- Break12
- Impedance Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- No Known Impact Or Consequence To Patient70
- Shock from Patient Lead(s)45
- Unspecified Infection26
- Pocket Erosion3
- Fall2
- Ventricular Fibrillation2
- Endocarditis1
Recent adverse event reports
The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2026Ambient Noise Problem
NOISE SEEN ON THE RV CHANNEL IN RECORDINGS STORED ON THE DEVICE. PATIENT TO BE ADMITTED FOR EXTRACTION. LEAD IS CURRENTLY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25451250 ↗InjuryMay 12, 2026Insufficient Device Problem Information
LEAD WAS CAPPED DUE TO A NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148552 ↗MalfunctionDec 15, 2025Ambient Noise Problem; Ambient Noise Problem
NOISE WAS REPORTED ON THIS RV LEAD. PER MD, DETECTION COUNTERS WERE INCREASED. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802278 ↗InjuryDec 12, 2025Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
P/S PORTION OF THIS RV LEAD WAS CAPPED ON (B)(6) 2025 DUE TO FRACTURE, >3000 OHM IMPEDANCE AND NOISE RESULTING IN 34 INAPPROPRIATE SHOCKS. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 23791362 ↗MalfunctionSep 11, 2025Fracture; Fracture
RV LEAD W FRACTURE ON P/S IS-1. THIS LEAD WAS PARTIALLY CAPPED (PACE/SENSE PORTION) DUE TO FRACTURE AND THE SHOCKING PORTION IS ACTIVE. 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 23027587 ↗InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22900076 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TOTAL SYSTEM EXTRACTION SECONDARY TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 22872963 ↗MalfunctionJul 17, 2025High impedance; High impedance
HMSC REPORTED SHOCK IMPEDANCE >150 OHM AND REMAINING ELEVATED. ALL OTHER VALUES ARE WITHIN RANGE. NO NOISE EVIDENT. ADVISED FURTHER LEAD EVALUATION. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536789 ↗InjuryJul 9, 2025Adverse 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 22461400 ↗MalfunctionApr 17, 2025Ambient 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 21861126 ↗MalfunctionMar 18, 2025Impedance Problem; Impedance Problem
THIS LEAD SHOWS ISSUES WITH SHOCK IMPEDANCE. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21632701 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION AND INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 20733927 ↗MalfunctionNov 11, 2024Ambient Noise Problem; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651630 ↗MalfunctionOct 16, 2024Break; Break
LEAD WAS CAPPED BECAUSE THE CONDUCTOR BECAME EXPOSED DURING DEVICE REMOVAL FROM POCKET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461270 ↗MalfunctionOct 3, 2024Failure to Capture; Failure to Capture
THIS LEAD WAS EXPLANTED DUE TO NO CAPTURE. 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 20359307 ↗MalfunctionSep 25, 2024High impedance; High impedance
HOME MONITORING REPORTED SHOCK IMPEDANCE GREATER THAN 150 OHM ON (B)(6) 2024. NO NOISE EVIDENT. ADVISED TO EVALUATE LEAD FURTHER. LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20304796 ↗MalfunctionSep 17, 2024Material Fragmentation; High impedance; Material Fragmentation; High impedance
LEAD SHOWED PACING IMPEDANCE OVER 2000. LEAD ATTEMPTED TO BE EXPLANTED BUT FELL APART SO THE SHOCK COIL AND TIP ARE STILL IN THE RV. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL B1028232-2024-04907E UPDATED.
Patient problems: Foreign Body In Patient
MAUDE report 20237827 ↗MalfunctionSep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS CAPPED DUE TO DISLODGEMENT DURING REVISION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199808 ↗MalfunctionSep 5, 2024Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated
THIS RV LEAD CAUSED INAPPROPRIATE SHOCKS DUE TO DISLODGEMENT. PROCEDURE TO REPLACE IS LIKELY TO HAPPEN TODAY ON (B)(6) 2024. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 20152299 ↗InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 20144914 ↗MalfunctionJun 5, 2024Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
THIS RV LEAD WAS EXPLANTED DUE TO NOISE AND 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 19471070 ↗MalfunctionMay 1, 2024Break; Break
THIS RV LEAD WAS CAPPED DUE TO IRREPARABLE DEFIBRILLATOR COIL DAMAGE. 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 19221511 ↗MalfunctionApr 25, 2024Impedance Problem; Unstable Capture Threshold; Impedance Problem; Unstable Capture Threshold
PACING IMPEDANCE AND PACING THRESHOLD SHOWED A MARKED INCREASE IN (B)(6) 2022 FROM ~500 OHMS TO ~1200 OHMS, AND 1.0V TO 2.0V, RESPECTIVELY. SINCE THEN, THEY HAVE SLOWLY TRENDED UP. THE SHOCK IMPEDANCE HAS ALSO TRENDED UP IN THE LAST YEAR. A FULL LEAD EVALUATION WAS RECOMMENDED. LEAD REMAINS IMPLANTED, NO ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19180454 ↗MalfunctionApr 24, 2024Low impedance; Ambient Noise Problem; Low impedance; Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO LOW IMPEDANCES, LESS THAN 200OHMS, AND 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 19171800 ↗MalfunctionApr 23, 2024High impedance; High impedance
THIS RV LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE. 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 19162734 ↗
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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