Selox ST 60 346367Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Selox ST 60 is a permanent pacemaker lead (electrode) for the right ventricle or right atrium. Most reports describe the lead's electrical readings going off — high impedance, failure to capture, or rising capture thresholds — sometimes with a fractured lead, and several leads were capped or removed, in a few cases because of infection. There are 47 reports, including 1 death and 11 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
- 47
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 04035479077853), received between Apr 2, 2019 and Jul 8, 2026 — classified as 1 death, 11 injuries, 35 malfunctions.
The most frequently reported specific device problem is “High impedance” (21 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- High impedance21
- High Capture Threshold10
- Adverse Event Without Identified Device or Use Problem9
- Failure to Capture8
- Fracture4
- Ambient Noise Problem2
- Device Dislodged or Dislocated2
- Impedance Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Known Impact Or Consequence To Patient17
- Unspecified Infection6
- Fall2
- Complete Heart Block1
- Dizziness1
- Dyspnea1
- Head Injury1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25754712 ↗InjuryMar 26, 2026High impedance
RV LEAD WAS EXPLANTED DUE TO IMPEDANCE WAS HIGH. 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 24706922 ↗MalfunctionAug 1, 2024Fracture; High impedance; Fracture; High impedance
THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCES AND FRACTURE. 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 19883002 ↗MalfunctionMay 9, 2022Failure to Capture; Failure to Capture
THIS LEAD WAS CAPPED DUE TO 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 14337820 ↗MalfunctionJan 24, 2022Impedance Problem; Impedance Problem
LEAD EXPLANTED DUE TO AN INCREASE IN IMPEDANCE MEASUREMENT OF THIS LEAD. 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 13338443 ↗MalfunctionOct 15, 2021Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold; Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold
PER REP (B)(6), LEAD WAS CAPPED DUE TO HIGH THRESHOLDS AND SENSING ISSUES AS WELL AS POSSIBLE MICRO-DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12641007 ↗MalfunctionSep 27, 2021High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem
CLINICIAN REPORTED BIPOLAR AND UNIPOLAR LEAD FAILURE ALERTS ON HOME MONITORING. IMPEDANCE MEASUREMENTS IN OFFICE SHOWED GREATER THAN 2000 OHMS BIPOLAR AND UNIPOLAR, AND CLINICIAN REPORTED THAT THERE MAY HAVE BEEN SOME NOISE OBSERVED DURING THRESHOLD TESTING. LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12533878 ↗MalfunctionAug 25, 2021Fracture; High impedance; Fracture; High impedance
LEAD CAPPED DUE TO FRACTURE. HM REPORTED BIPOLAR LEAD FAILURE AND SWITCH TO UNIPOLAR POLARITY. PACING IMPEDANCE HAS BEEN VARIABLE AND WAS HIGH BEFORE INTERVENTION. 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 12368096 ↗DeathJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOR UNKNOWN REASONS APPROX. 36 MONTHS AFTER THE PACEMAKER IMPLANTATION. THE PACEMAKER WAS ALREADY REPORTED ON THE (B)(6) 2021. WITH THE PRODUCT ARRIVAL ON THE (B)(6) 2021 ALSO THE TWO IMPLANTED LEADS WERE RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12139999 ↗InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LEAD EXPLANTED DUE TO INFECTION. PER PATIENT WIFE, PACER AND LEADS WERE REMOVED DUE TO THE CAPPED LEAD BEING INFECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 11803555 ↗InjuryApr 22, 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 11710748 ↗MalfunctionApr 9, 2021High impedance; High Capture Threshold; High impedance; High Capture Threshold
LEAD CAPPED DUE TO HIGH PACING IMPEDANCE >2500. THRESHOLD 5.1 V. 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 11642546 ↗MalfunctionMar 30, 2021High impedance; High impedance
AFTER AN IMPLANTATION PERIOD OF APPROX. 87 MONTHS, THE RV LEAD IMPEDANCE TREND SHOWED A STEADY INCREASE. FURTHERMORE AN LEAD FAILURE ALERT WAS REPORTED. THE PATIENT UNDERWENT SURGERY FOR A NEW RV LEAD AND THE LEAD WAS CAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11593306 ↗MalfunctionJan 21, 2021High impedance; High impedance
IMPEDANCE INCREASED TO >2500 OHMS. LEAD WAS CAPPED. NO ADVERSE PATIENT EVENTS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11207380 ↗MalfunctionDec 4, 2020High Capture Threshold; High Capture Threshold
THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLDS. 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 10945391 ↗MalfunctionNov 18, 2020Failure to Capture; High impedance; Failure to Capture; High impedance
LEAD WAS REMOVED DUE TO HIGH IMPEDANCE AND FAILURE TO CAPTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10861359 ↗MalfunctionNov 11, 2020High Capture Threshold; High Capture Threshold
AFTER A REVIEW OF OUR RECORDS, THIS EVENT WAS RECOGNIZED AS REPORTABLE TO THE COMPETENT AUTHORITY. THE PATIENT IMPLANTED WITH THIS LEAD WAS PLACED ON HOMEMONITORING DUE TO INCREASING VENTRICULAR THRESHOLD. THE PATIENT IS PACEMAKER DEPENDENT. THE THRESHOLD ROSE OVER 3V AND IT WAS DECIDED TO REPLACE THE LEAD. A NEW LEAD (SOLIA) AND A NEW PACEMAKER WERE IMPLANTED ON (B)(6) 2020. THIS SELOX LEAD WAS CAPPED AND REMAINS IN SITU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10825616 ↗MalfunctionOct 9, 2020High impedance; High impedance
LEAD WAS CAPPED AND REPLACE DUE TO HIGH IMPEDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10658479 ↗MalfunctionSep 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10573968 ↗MalfunctionSep 16, 2020Failure to Capture; High impedance; Failure to Capture; High impedance
LEAD STATUS SHOWED IMPEDANCE >2500 OHMS IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATION. THERE WAS ALSO NO CAPTURE AT MAXIMUM OUTPUT. LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED ON (B)(6) 2020. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10544225 ↗MalfunctionSep 16, 2020High impedance; High impedance
RV LEAD HAD DEVELOPED A STEADILY RISING LEAD IMPEDANCE. THIS LEAD WAS THEREFORE CAPPED AND REPLACED BY A NEW RV PACE/SENSE LEAD ON (B)(6) 2020. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10541183 ↗MalfunctionSep 1, 2020High Capture Threshold; High Capture Threshold
THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH THRESHOLDS. 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 10478577 ↗MalfunctionJul 21, 2020High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold
RV LEAD WITH INCREASING AND UNSTABLE THRESHOLD. LEAD WAS EXPLANTED. 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 10303022 ↗InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. TEMPORARY SYSTEM IMPLANTED. NEW SYSTEM WAS IMPLANTED (B)(6) 2020. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9962337 ↗MalfunctionFeb 7, 2020High impedance; High impedance
THIS LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE. 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 9682646 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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