Linox Smart TD 65/16 359073Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a BIOTRONIK Linox Smart TD defibrillator lead, an implanted wire that connects a defibrillator to the heart. There are 24 reports naming this device, with no deaths and 5 injuries. Reports mostly describe the lead picking up electrical noise or misreading heart signals, sometimes causing inappropriate shocks or high impedance, and in some cases the lead was capped or fractured. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04035479100469), received between Aug 22, 2019 and Jul 20, 2022 — classified as 5 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (9 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
- Over-Sensing9
- Ambient Noise Problem7
- Inappropriate/Inadequate Shock/Stimulation5
- High impedance4
- Fracture3
- Device Dislodged or Dislocated1
- Failure to Capture1
- High Capture Threshold1
Patient problems
- No Known Impact Or Consequence To Patient10
- No Clinical Signs, Symptoms or Conditions9
- Shock from Patient Lead(s)5
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2022Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 142 MONTHS IT WAS REPORTED THAT THE LEAD WAS CAPPED DUE TO OVERSENSING IN THE VENTRICULAR CHANNEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15068257 ↗MalfunctionJun 29, 2022Failure to Capture; High impedance; Failure to Capture; High impedance
THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCES, GREATER THAN 3000, AND LOSS OF 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 14851893 ↗MalfunctionMay 31, 2022Ambient Noise Problem; Ambient Noise Problem
NOISE WAS OBSERVED ON THIS RV LEAD SO THE ICD DISABLED. 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
MAUDE report 14547225 ↗MalfunctionJan 4, 2022Ambient Noise Problem; Ambient Noise Problem
THE LEAD WAS IMPLANTED ON (B)(6) 2011. (THE ICD WAS REPLACED ON (B)(6) 2020.) NOISE ON RV LEAD WAS DISCOVERED IN RECORDINGS, WITHOUT INAPPROPRIATE SHOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13157776 ↗MalfunctionOct 15, 2021Fracture; Ambient Noise Problem; Fracture; Ambient Noise Problem
LEAD CAPPED DUE TO FRACTURE CAUSING 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 12641026 ↗InjuryJun 16, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 110 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. APART FROM THE SHOCKS, NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS CAPPED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 12013584 ↗MalfunctionApr 21, 2021Ambient Noise Problem; Ambient Noise Problem
NOISE ON RV LEAD. THE DOCTOR HAS EXTENDED THE DETECTION. THE LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11704140 ↗MalfunctionApr 19, 2021Over-Sensing; Over-Sensing
OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE DETECTION WAS EXTENDED. THE LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11691206 ↗InjuryMar 30, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
THE PACE/SENSE PORTION OF THIS LEAD WAS CAPPED DUE TO INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 11593111 ↗MalfunctionMar 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AFTER AN IMPLANTATION PERIOD OF APPROX. 85 MONTHS, A DISLODGEMENT OF THE RV LEAD WAS OBSERVED. THE PHYSICIAN DECIDED TO CAP THE LEAD AND ADD A NEW LEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11454283 ↗MalfunctionFeb 17, 2021Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem
NOISE PRESENT ON RV ELECTRODE DURING RV PACING ONLY. ODD VARIANCE IN RV LEAD IMPEDANCE TREND AS WELL. LEAD WILL BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11340512 ↗InjuryAug 26, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 101 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. THE LEADS WERE CAPPED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10454726 ↗MalfunctionJun 4, 2020Over-Sensing; Over-Sensing
IT WAS REPORTED THAT APPROX. 114 MONTHS AFTER THE IMPLANTATION, VENTRICULAR OVERSENSING WAS REPORTED. THIS LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10121241 ↗InjuryJun 4, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 110 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. FURTHERMORE IT WAS OBSERVED THAT THE ELECTRICAL PARAMETERS RESULTED IN NORMAL RANGE AND THE TRENDS ARE STABLE. APART FROM THE SHOCKS, NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10121232 ↗InjuryJun 4, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
AFTER AN IMPLANTATION PERIOD OF APPROX. 99 MONTHS, OVERSENSING WITH INAPPROPRIATE THERAPIES WAS REPORTED. FURTHERMORE IT WAS OBSERVED THAT DURING THE FOLLOW-UP TESTS THAT THE REMAINING ELECTRICAL PARAMETERS WERE IN NORMAL RANGE. APART FROM THE SHOCKS, NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10121224 ↗MalfunctionMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THIS LEAD WAS CAPPED AND REPLACED DUE TO LEAD FAILURE. 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 10094211 ↗MalfunctionApr 28, 2020Ambient 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 Known Impact Or Consequence To Patient
MAUDE report 10005828 ↗MalfunctionMar 25, 2020Over-Sensing; Over-Sensing
AFTER AN IMPLANTATION PERIOD OF APPROX. 108 MONTHS, OVERSENSING ON THE VENTRICULAR CHANNEL WAS REPORTED. THE LEAD WAS CAPPED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9881332 ↗MalfunctionMar 11, 2020High impedance; High impedance
AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 106 MONTHS, IT WAS REPORTED THAT THE SHOCK IMPEDANCE WAS TOO HIGH. THE LEADS WERE CAPPED AND THE ICD WAS IMPLANTED ON THE RIGHT SIDE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9820418 ↗MalfunctionDec 6, 2019Over-Sensing; Over-Sensing
APPROXIMATELY 111 MONTHS AFTER IMPLANTATION, VENTRICULAR OVERSENSING WAS REPORTED WHICH COULD BE REPRODUCED DURING CLINICAL FOLLOW UP. THE PHYSICIAN DECIDED TO REPROGRAM AND MONITOR PATIENT FURTHER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9433646 ↗MalfunctionDec 2, 2019High impedance; Under-Sensing; Ambient Noise Problem; High impedance; Under-Sensing; Ambient Noise Problem
THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH IMPEDANCES, UNDERSENSING 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 9396546 ↗MalfunctionDec 2, 2019High Capture Threshold; High Capture Threshold
WE WERE NOTIFIED THAT THIS RV LEAD WAS PARTIALLY CAPPED DUE TO HIGH THRESHOLDS ON (B)(6) 2013. SHOCK PORTION STILL ACTIVE. 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 9395011 ↗MalfunctionNov 11, 2019Fracture; Fracture
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO FRACTURE. 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 9306774 ↗MalfunctionAug 22, 2019Fracture; High impedance; Fracture; High impedance
THIS LEAD WAS CAPPED AND REPLACED DUE TO SUSPECTED FRACTURE AND IMPEDANCES OVER 3000 OHMS. 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 8923047 ↗
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.
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