Linox Smart S DX 65/17 365501Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Linox Smart S defibrillator lead is a wire implanted in the heart that carries shock and pacing signals. Many of the 289 reports describe electrical noise, high resistance readings, and wire fractures, and some describe unexpected shocks. Some leads were switched off or removed after these problems. The reports include no deaths and 85 injuries. No recalls name this device.
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
- 290
- Deaths reported
- 0
- Injuries reported
- 86
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 290 adverse event reports that list this exact device (DI 04035479110024), received between Aug 12, 2018 and Sep 28, 2026 — classified as 86 injuries, 204 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (129 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.
Reports received per month
Most reported problems
Device problems
- Ambient Noise Problem129
- High impedance62
- Inappropriate/Inadequate Shock/Stimulation40
- Fracture37
- Adverse Event Without Identified Device or Use Problem33
- Over-Sensing25
- Device Sensing Problem17
- High Capture Threshold16
Patient problems
- No Clinical Signs, Symptoms or Conditions160
- No Known Impact Or Consequence To Patient51
- Shock from Patient Lead(s)40
- Unspecified Infection32
- Twiddlers Syndrome3
- Ventricular Fibrillation3
- Fall1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 290 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Impedance Problem
This lead was explanted due to OOR shock 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 50916445 ↗InjurySep 16, 2026Ambient Noise Problem
This lead was capped due to noise. 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 50788086 ↗InjuryAug 6, 2026Fracture; High impedance
This lead was explanted due to increased impedance above normal range consistent with possible lead 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 50164028 ↗InjuryAug 4, 2026Insufficient Device Problem Information
This lead was explanted due to chronic lead malfunction. Should additional information become available, this file will be updated.
Patient problems: Insufficient Information
MAUDE report 50134817 ↗InjuryMay 26, 2026Ambient Noise Problem
THIS LEAD WAS CAPPED DUE TO NOISE. 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 25290108 ↗InjuryApr 15, 2026Failure to Capture; High impedance; High Capture Threshold
LEAD WAS CAPPED DUE TO HIGH THRESHOLD (FAILURE TO CAPTURE AT MAX OUTPUT) AND HIGH PACING IMPEDANCE OF 2,700+ OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891061 ↗InjuryApr 9, 2026Fracture
THIS LEAD WAS CAPPED DUE TO FRACTURED LEAD. 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 24829866 ↗InjuryApr 8, 2026Fracture
THIS RV LEAD WAS EXPLANTED DUE TO FRACTURE. NO OTHER 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 24822183 ↗MalfunctionFeb 25, 2026High impedance
HOME MONITORING TREND FOR SHOCK IMPEDANCE OUT OF RANGE GREATER THAN 150 OHMS INTERMITTENTLY SINCE FEBRUARY 6. THE LAST TWO DAYS HAS RETURNED TO NORMAL. PATIENT WAS CHECKED IN OFFICE THIS MORNING AND IMPEDANCE WAS NORMAL AND NO NOISE SEEN. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24450114 ↗MalfunctionFeb 12, 2026Ambient Noise Problem
HMSC SHOWED RV LEAD MONITORING RECORDING SHOWING NOISE ON RV AND FF CHANNEL. ALL LEAD TRENDS APPEAR UNREMARKABLE. SHORT INTERVAL COUNTER INCREASING SINCE (B)(6) 2026. 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 24327390 ↗InjuryFeb 5, 2026Fracture; Ambient Noise Problem; Impedance Problem
HMSC REPORTED SHOCK IMPEDANCE OUT OF RANGE ON 5-FEB-2026, THE DAY AFTER A GENERATOR CHANGEOUT. RECORDINGS SHOWS NOISE ON ATRIAL CHANNEL OF LEAD. LEAD TO BE EVALUATED FURTHER AND CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274000 ↗InjuryFeb 3, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
HMSC REPORTED NOISE RESULTING IN INAPPROPRIATE SHOCKS AND TEMPORARY INCREASE IN PACING IMPEDANCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. LEAD REMAINS IMPLANTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 24248127 ↗InjuryJan 29, 2026Over-Sensing
THIS LEAD WAS EXPLANTED DUE TO OVERSENSING. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24216947 ↗InjuryJan 26, 2026High Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO ELEVATED THRESHOLDS. 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 24178255 ↗InjuryJan 14, 2026Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
THIS RV LEAD WAS CAPPED DUE TO NOISE LEADING TO INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 24066828 ↗InjuryJan 12, 2026Ambient Noise Problem
HMSC REPORTED LEAD NOISE ON ATRIAL AND RV CHANNEL RESULTING IN VF DETECTION ON (B)(6) 2025. SHOCK THERAPY ABORTED. LEAD TRENDS APPEAR STABLE. NOISE WAS NOT REPRODUCIBLE DURING OFFICE INTERROGATION ON (B)(6) 2026. FURTHER EVALUATION TO BE DISCUSSED WITH PHYSICIAN. LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24038522 ↗MalfunctionDec 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS RV LEAD WAS CUT AT YOKE AND CAPPED DUE TO LEAD COMPROMISE AND INAPPROPRIATE THERAPIES. NO FURTHER DETAILS KNOWN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927394 ↗MalfunctionDec 9, 2025High impedance; High impedance
THE SHOCK IMPEDANCE HAS TRENDED >150 OHMS SINCE (B)(6) 2025. OTHER LEAD TRENDS APPEARED STABLE AND WITHIN NORMAL RANGE. THE PATIENT WILL BE BROUGHT IN FOR A LEAD EVALUATION. LEAD REMAINS IMPLANTED. NO ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23761976 ↗MalfunctionNov 25, 2025High impedance; High impedance
THIS LEAD SHOWS INCREASING SHOCK IMPEDANCE AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23652453 ↗MalfunctionNov 20, 2025High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem
HMSC REPORTED EPISODES SHOWING NOISE ON ATRIAL CHANNEL AND A SUDDEN INCREASE IN SHOCK IMPEDANCE IN APRIL 2025. ADVISED FURTHER LEAD EVALUATION. 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 23609699 ↗MalfunctionOct 17, 2025Impedance Problem; Impedance Problem
THIS LEAD WAS CAPPED DUE TO IMPEDANCE DROPS. 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 23327572 ↗MalfunctionSep 11, 2025Ambient Noise Problem; Ambient Noise Problem
ATRIAL NOISE REPORTED ON HOME MONITORING EPISODES. THESE SEEM TO HAVE STARTED IN JULY INTERMITTENTLY BUT PATIENT DID HAVE A RECENT IN OFFICE FOLLOW UP IN JUNE WHERE ALL WAS NORMAL. ALL OTHER TRENDS APPEAR STABLE. 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 23025960 ↗MalfunctionAug 29, 2025Break; Break
WHEN SCREWING THIS LED INTO NEW DEVICE, MD PLUGGED RV COIL IN, TURNED SCREW, AND WHEN HE GENTLY TUGGED THE ENTIRE LEAD TORE (LEAVING PIN IN HEADER AND EXPOSED WIRES ON LEAD). THE LEAD WAS CAPPED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22926846 ↗InjuryAug 22, 2025Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem; Inappropriate/Inadequate Shock/Stimulation; Ambient Noise Problem
NOISE SEEN ON RECORDINGS. SHORT INTERVALS GRAPH ALSO POPULATING WITH EVENTS THAT CAN BE INDICATIVE OF LEAD NOISE. LEAD REMAINS 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; Shock from Patient Lead(s)
MAUDE report 22875224 ↗MalfunctionAug 21, 2025Impedance Problem; Impedance Problem
THIS RV LEAD WAS EXPLANTED DUE TO IMPEDANCE OUT OF RANGE. 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 22866065 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page