DEXTRUS 4137Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Dextrus 4137 pacemaker lead is an implanted electrode that carries signals between the heart and a pacemaker. Its 560 reports mostly describe electrical noise, false sensing and high readings for pacing threshold or impedance, and many list no clinical signs in the patient. Some describe infection, including sepsis, and fainting. The reports include 3 deaths and 152 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
- 560
- Deaths reported
- 3
- Injuries reported
- 152
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 560 adverse event reports that list this exact device (DI 04035479143220), received between Jun 20, 2018 and Aug 8, 2022 — classified as 3 deaths, 152 injuries, 405 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (145 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
- Ambient Noise Problem145
- Adverse Event Without Identified Device or Use Problem135
- Over-Sensing107
- Insufficient Device Problem Information90
- High Capture Threshold66
- High impedance64
- Pacing Intermittently52
- Failure to Capture48
Patient problems
- No Clinical Signs, Symptoms or Conditions207
- No Known Impact Or Consequence To Patient177
- Unspecified Infection129
- Sepsis42
- Syncope11
- Dizziness9
- Pocket Erosion9
- Syncope/Fainting8
Recent adverse event reports
The 25 most recent of 560 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 15188156 ↗MalfunctionAug 8, 2022High Capture Threshold; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO HIGH PACING 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 15184715 ↗MalfunctionAug 8, 2022Ambient Noise Problem; Impedance Problem; High Capture Threshold; Ambient Noise Problem; Impedance Problem; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS DISPLAYING NOISE WITH DECREASING IMPEDANCES AND INCREASING THRESHOLDS. LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183298 ↗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 15183275 ↗MalfunctionAug 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: AN UNSPECIFIED ISSUE WITH THE RV LEAD WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158129 ↗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 15158105 ↗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 15142744 ↗MalfunctionJul 25, 2022Intermittent Capture; High impedance; Intermittent Capture; High impedance
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED AND REPLACED DUE TO HIGH IMPEDANCES WITH INTERMITTENT CAPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15100290 ↗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 A STAPH INFECTION AND IS WAITING TO HAVE SYSTEM EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 15089934 ↗MalfunctionJul 20, 2022Ambient Noise Problem; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED IN 2021 DUE TO NOISE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15068178 ↗MalfunctionJul 20, 2022Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS CAPPED DUE TO NOISE, OVERSENSING, LOSS OF CAPTURE AND ASYSTOLE GREATER THAN 2 SECONDS. A LEAD FRACTURE AND IMPEDANCES GREATER THAN 2500 OHMS WERE OBSERVED AS WELL.
Patient problems: Asystole
MAUDE report 15068176 ↗MalfunctionJul 5, 2022Over-Sensing; Pacing Intermittently; Ambient Noise Problem; Over-Sensing; Pacing Intermittently; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: RV LEAD WAS CAPPED/ABANDONED DUE TO NOISE, OVERSENSING AND PACING INHIBITION. ASYSTOLE LESS THAN 2 SECONDS. A NEW RV LEAD WAS PLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14920253 ↗MalfunctionJul 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THE LEAD WAS CAPPED ON (B)(6) 2022 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 14920216 ↗MalfunctionJul 5, 2022Over-Sensing; Pacing Intermittently; Ambient Noise Problem; Over-Sensing; Pacing Intermittently; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT LEAD NOISE/OVERSENSING CAUSED PACING INHIBITION. THE LEAD WAS REMOVED AND REPOSITIONED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14919692 ↗MalfunctionJun 30, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: PATIENT WAS ADMITTED TO HOSPITAL DUE TO MULTIPLE SYNCOPE EPISODES. LEAD WAS CAPPED DUE TO POSSIBLE DISLODGEMENT AND FAILURE TO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Syncope/Fainting
MAUDE report 14881101 ↗MalfunctionJun 30, 2022Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: RV LEAD CAPPED/ABANDONED ON (B)(6)2022 DUE TO NOISE IN ISOMETRICS AND OVERSENSING WITH NO PACING INHIBITION. 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 14881026 ↗MalfunctionJun 28, 2022Failure to Capture; Failure to Capture
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: LEAD WAS CAPPED ON (B)(6) 2022 DUE TO LOSS OF CAPTURE. 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 14841666 ↗MalfunctionJun 27, 2022High Capture Threshold; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: RV LEAD WAS CAPPED/ABANDONED DUE TO HIGH PACING THRESHOLDS. 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 14837072 ↗InjuryJun 27, 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 14837060 ↗MalfunctionJun 27, 2022Over-Sensing; Pacing Intermittently; Ambient Noise Problem; Over-Sensing; Pacing Intermittently; Ambient Noise Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: RV LEAD WAS EXPLANTED DUE TO NOISE, OVERSENSING & PACING INHIBITION. NO ASYSTOLE. 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 14837029 ↗InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THE LEAD WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 14732546 ↗MalfunctionJun 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS LEAD WAS CAPPED DUE TO UNSPECIFIED 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 14696405 ↗InjuryJun 6, 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 14605233 ↗MalfunctionJun 2, 2022High Capture Threshold; High Capture Threshold
BOSTON SCIENTIFIC PROVIDED THE FOLLOWING INFORMATION: THIS RV LEAD WAS CAPPED DUE TO HIGH PACING THRESHOLDS. 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 14579580 ↗InjuryJun 1, 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 DUE TO INFECTION/SEPSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 14565311 ↗
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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