Setrox S 53 350974Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Setrox pacemaker lead appears in 870 adverse event reports, including 1 death and 332 injuries. Many describe electrical noise in heart readings, high stimulation thresholds, and leads moving or breaking, with some mentioning infections that led to removal of the whole system. 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
- 873
- Deaths reported
- 1
- Injuries reported
- 335
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 873 adverse event reports that list this exact device (DI 04035479087951), received between Feb 16, 2016 and Sep 17, 2026 — classified as 1 death, 335 injuries, 537 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (188 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
- Adverse Event Without Identified Device or Use Problem304
- Ambient Noise Problem188
- High Capture Threshold97
- Device Dislodged or Dislocated82
- High impedance77
- Fracture72
- Failure to Capture65
- Break38
Patient problems
- No Clinical Signs, Symptoms or Conditions347
- Unspecified Infection267
- No Known Impact Or Consequence To Patient202
- Pocket Erosion16
- Bacteremia7
- Endocarditis6
- Sepsis6
- Twiddlers Syndrome6
Recent adverse event reports
The 25 most recent of 873 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Sepsis
MAUDE report 50811937 ↗InjurySep 16, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796755 ↗InjurySep 11, 2026Fracture; Ambient Noise Problem
This lead was explanted due to noise and suspected fracture. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50733656 ↗InjurySep 2, 2026Adverse 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 50565834 ↗MalfunctionAug 26, 2026Ambient Noise Problem
HMSC reported episodes showing noise since generator replacement on (b)(6) 2026. Short interval counter >249 since then. All other lead trends appear unremarkable. Lead currently remains implanted. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455681 ↗MalfunctionAug 20, 2026Fracture; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356172 ↗InjuryAug 10, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50199142 ↗InjuryJun 24, 2026Adverse 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 25611892 ↗InjuryJun 24, 2026Adverse 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 25611876 ↗InjuryJun 22, 2026Break; Fracture; Low impedance; High Capture Threshold
THIS LEAD WAS CAPPED DUE TO HIGH CAPTURE THRESHOLD, LOW IMPEDANCE, FRACTURE AND INSULATION BREAK. 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 25585606 ↗InjuryJun 15, 2026Adverse 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 25512578 ↗InjuryMay 27, 2026Fracture
LEAD WAS CAPPED 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 25309550 ↗MalfunctionMay 26, 2026Ambient Noise Problem; Unstable Capture Threshold
DEVICE SHOWED NOISE ON RA LEAD DURING INTERROGATION ON (B)(6) 2026. NOISE WAS REPRODUCIBLE DURING ISOMETRICS. NO STABLE THRESHOLD. LEAD TO BE EVALUATED FURTHER. LEAD CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25286033 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BACTEREMIA INFECTION WITH SEPSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia; Sepsis
MAUDE report 25177575 ↗MalfunctionApr 28, 2026Ambient Noise Problem; Device Sensing Problem
HMSC REPORTED EPISODE SHOWING NOISE RESULTING IN AT DETECTION ON (B)(6) 2026. ALL LEAD TRENDS APPEAR STABLE. LEAD CURRENTLY 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 25023433 ↗InjuryMar 30, 2026High Capture Threshold
THIS LEAD WAS CAPPED DUE TO CHRONIC HIGH THRESHOLD. 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 24736881 ↗InjuryMar 30, 2026Impedance Problem
RA LEAD WAS CAPPED DUE TO OUT OF RANGE IMPEDANCE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736431 ↗MalfunctionMar 25, 2026Ambient Noise Problem
IT WAS REPORTED THAT WHAT APPEARS TO BE INTERMITTENT NOISE WAS SEEN ON THE ATRIAL CHANNEL. FURTHER EVALUATION WAS RECOMMENDED. 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 24686224 ↗InjuryMar 24, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24677132 ↗InjuryMar 12, 2026Failure to Capture; Device Sensing Problem
THIS RV LEAD WAS CAPPED DUE TO LOW SENSING AND NO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584931 ↗InjuryMar 5, 2026High Capture Threshold
LEAD WAS CAPPED DUE TO HIGH THRESHOLD. 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 24526252 ↗MalfunctionMar 5, 2026Ambient Noise Problem
HMSC REPORTED EPISODES SHOWING NOISE. 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 24515097 ↗MalfunctionFeb 23, 2026Unstable Capture Threshold
PATIENT HAS EXPERIENCED TWO SIGNIFICANT JUMPS IN RV THRESHOLD SINCE CHANGEOUT, BOTH RESULTING IN ER VISITS DUE TO DIZZINESS AS SHE IS DEPENDENT. NO UNDERLYING LEAD INTEGRITY ISSUE COULD BE IDENTIFIED FROM LEAD TREND DATA AS IMPEDANCE IS STABLE AND NO NOISE IS PRESENT IN RECORDINGS. PROVOCATIVE MOVEMENTS AND POCKET MANIPULATION REVEALED NO NOISE AND NO CHANGE IN IMPEDANCE MEASUREMENTS. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Dizziness
MAUDE report 24413695 ↗InjuryFeb 20, 2026Ambient Noise Problem
RA 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 24400100 ↗InjuryFeb 9, 2026Break
THIS LEAD WAS CAPPED DUE TO IT BROKE WHILE PHYSICIAN WAS TRYING TO REMOVE IT FROM THE DEVICE HEADER DURING CHANGE-OUT. 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 24291902 ↗
Other Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes devices
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes438 deaths19,632 reports
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes200 deaths12,708 reports
- INGEVITY™ MRI 7741Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes36 deaths7,874 reports
- INGEVITY™+ 7841Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes15 deaths7,419 reports
- Tendril™ STSSt. Jude Medical, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes190 deaths6,776 reports
- INGEVITY™+ 7842Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes21 deaths5,995 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes50 deaths5,027 reports
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes40 deaths5,000 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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