DEXTRUS 4136Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This Biotronik Dextrus pacemaker lead is an implanted wire that connects a pacemaker to the heart. Many of its 1,084 reports describe electrical noise, sensing problems and high impedance, and some describe infections that led to removal of the lead. The reports include 5 deaths and 381 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
- 1,084
- Deaths reported
- 5
- Injuries reported
- 381
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,084 adverse event reports that list this exact device (DI 04035479143213), received between Nov 29, 2016 and Aug 8, 2022 — classified as 5 deaths, 381 injuries, 698 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (234 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem348
- Ambient Noise Problem234
- Over-Sensing190
- Insufficient Device Problem Information164
- High Capture Threshold108
- High impedance95
- Pacing Intermittently77
- Failure to Capture70
Patient problems
- No Clinical Signs, Symptoms or Conditions364
- Unspecified Infection334
- No Known Impact Or Consequence To Patient290
- Sepsis106
- Pocket Erosion26
- Syncope/Fainting14
- Dizziness12
- Syncope11
Recent adverse event reports
The 25 most recent of 1,084 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: NON-PHYSIOLOGIC TACHYCARDIA EVENTS WITH NOISE (NO SYNCOPE) WERE OBSERVED ON BOTH CHANNELS. PATIENT IS DEVICE DEPENDENT. MAXIMUM LENGTH OF EVENT WAS 4 SECONDS. LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15188114 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 15183304 ↗MalfunctionAug 3, 2022Fracture; Fracture
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO A SUSPECTED 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 15158137 ↗MalfunctionAug 3, 2022Fracture; High impedance; Fracture; High impedance
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS CAPPED DUE TO A FRACTURE AND HIGH IMPEDANCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158135 ↗MalfunctionAug 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS EXPLANTED AND REPLACED DUE TO A PRODUCT PERFORMANCE ISSUE. NO OTHER INFORMATION WAS PROVIDED. 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 15158117 ↗MalfunctionAug 3, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: NOISE WAS REPORTED ON THIS LEAD. LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158113 ↗InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15158095 ↗InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15142711 ↗InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION AND SEPSIS.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 15142709 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15127394 ↗MalfunctionJul 29, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD SHOWED NOISE AND WAS EXPLANTED AND REPLACED. 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 15127387 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15127382 ↗MalfunctionJul 29, 2022Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA LEAD HAS OVERSENSING AND AN IMPEDANCE ISSUE. IT APPEARS THE LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15127330 ↗MalfunctionJul 26, 2022Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS EXPLANTED DUE TO OVERSENSING OF NOISE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103964 ↗MalfunctionJul 25, 2022High impedance; High impedance
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO HIGH IMPEDANCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15100289 ↗MalfunctionJul 25, 2022Unstable Capture Threshold; Unstable Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: POSSIBLE CAPTURE ISSUES WERE REPORTED ON THIS LEAD. THE PATIENT EXPERIENCED SYNCOPE. THE LEAD REMAINS ACTIVELY IMPLANTED.
Patient problems: Syncope/Fainting
MAUDE report 15100288 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: PATIENT HAS STAPH INFECTION AND IS WAITING TO HAVE SYSTEM EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15089903 ↗InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15089899 ↗MalfunctionJul 20, 2022Under-Sensing; Under-Sensing
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO UNDERSENSING. 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 15068214 ↗MalfunctionJul 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO A PRODUCT PERFORMANCE ISSUE. NO OTHER INFORMATION WAS PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15068187 ↗MalfunctionJul 20, 2022Over-Sensing; Low impedance; Over-Sensing; Low impedance
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO LOW IMPEDANCES AND OVERSENSING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15068172 ↗MalfunctionJul 20, 2022Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: OVERSENSING OF NOISE WAS SEEN ON RV LEAD. IT IS UNCLEAR IF THE LEAD IS STILL IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15066967 ↗MalfunctionJul 13, 2022Under-Sensing; Device Sensing Problem; Under-Sensing; Device Sensing Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA LEAD WAS EXPLANTED DUE TO UNDERSENSING AND LOW AMPLITUDE/POOR MORPHOLOGY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15001216 ↗MalfunctionJul 13, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: AN INCREASE IN THRESHOLDS RESULTED IN INTERMITTENT LOSS OF CAPTURE. THIS LEAD WAS EXPLANTED AND REPLACED DURING A DEVICE CHANGE OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15000395 ↗InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANTED DUE TO INFECTION/SEPSIS.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 14977561 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.