DEXTRUS 4135Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This Biotronik Dextrus lead is a wire placed in the heart to carry pacing signals from a pacemaker. Many of its 490 reports describe noise, poor sensing and high electrical resistance, and infection was reported for many patients. Recent reports describe leads being abandoned or removed after sensing problems or fractures. The reports include 169 injuries and 2 deaths. 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
- 490
- Deaths reported
- 2
- Injuries reported
- 169
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 490 adverse event reports that list this exact device (DI 04035479143206), received between Feb 25, 2016 and Nov 25, 2025 — classified as 2 deaths, 169 injuries, 319 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (100 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
- Adverse Event Without Identified Device or Use Problem156
- Ambient Noise Problem100
- Insufficient Device Problem Information81
- Over-Sensing79
- High impedance45
- High Capture Threshold44
- Device Dislodged or Dislocated30
- Failure to Capture26
Patient problems
- No Clinical Signs, Symptoms or Conditions183
- Unspecified Infection150
- No Known Impact Or Consequence To Patient123
- Sepsis34
- Pocket Erosion16
- Fall5
- Undesired Nerve Stimulation4
- Dizziness3
Recent adverse event reports
The 25 most recent of 490 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2025Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO POOR SENSING. ANOTHER RA LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645760 ↗InjuryMay 10, 2023No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO IT PRESENTING UNDERSENSING ISSUES, WITH THE ISSUE TRACED BACK TO THE LEAD BY EXAMINING THE LEAD BY PACING SYSTEM ANALYZER (PSA). A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16904098 ↗MalfunctionAug 8, 2022High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA LEAD WAS EXPLANTED DUE TO HIGH SHOCK IMPEDANCE AND 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 15184716 ↗MalfunctionAug 3, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA LEAD WAS DISLODGED WITH LOSS OF CAPTURE. THE DEVICE WAS REPROGRAMMED. THE LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158123 ↗MalfunctionAug 3, 2022Fracture; Fracture
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS EXPLANTED DUE TO A 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 15158120 ↗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 15127391 ↗MalfunctionJul 29, 2022Fracture; Fracture
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS EXPLANTED DUE TO A 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 15127390 ↗MalfunctionJul 29, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RA 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 15127388 ↗MalfunctionJul 26, 2022Over-Sensing; Pacing Intermittently; Ambient Noise Problem; Over-Sensing; Pacing Intermittently; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS EXPLANTED DUE TO OVERSENSING OF NOISE AND PACING INHIBITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103938 ↗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; Unspecified Infection
MAUDE report 15068218 ↗MalfunctionJul 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO A NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. 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 14920200 ↗MalfunctionJul 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. 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 14919717 ↗InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: SYSTEM WAS EXPLANTED ON (B)(6) 2022 DUE TO INFECTION/SEPSIS AND POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Sepsis; Unspecified Infection
MAUDE report 14880959 ↗InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: PATIENT HAS A BLOOD INFECTION WHICH MAY LEAD TO A FULL SYSTEM EXTRACTION. LEAD REMAINS IMPLANTED AND ACTIVE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 14847771 ↗MalfunctionJun 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: RA LEAD WAS CAPPED DUE TO A NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. 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 14837348 ↗InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: LEAD WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 14837334 ↗MalfunctionJun 27, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: NOISE WAS OBSERVED ON ATRIAL EGM. 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 14836968 ↗InjuryJun 24, 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 BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 14804370 ↗MalfunctionJun 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: RA LEAD WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. 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 14784013 ↗MalfunctionJun 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: LEAD WAS CAPPED AND NEW ATRIAL LEAD IMPLANTED DURING GENERATOR CHANGE. 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 14743956 ↗MalfunctionJun 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: LEAD WAS CAPPED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. 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 14743952 ↗MalfunctionJun 20, 2022Over-Sensing; Over-Sensing
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: ATRIAL OVERSENSING WAS REPORTED. 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 14743949 ↗InjuryJun 20, 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 BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 14743946 ↗MalfunctionJun 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT LEAD WAS EXPLANTED ON (B)(6) 2022 DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. 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 14732608 ↗MalfunctionJun 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: LEAD WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. 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 14732564 ↗
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.