Solia S 45 377176Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is the Biotronik Solia S 45 pacemaker lead, a drug-eluting electrode placed in the heart's right chambers. The 1,695 reports mostly describe the lead moving out of place, electrical noise in the signal, and failure to pace the heart reliably, with infections also mentioned. Several describe the lead being removed. The records include 6 deaths, 798 injuries and 891 malfunctions, and 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
- 1,702
- Deaths reported
- 6
- Injuries reported
- 805
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,702 adverse event reports that list this exact device (DI 04035479118259), received between Oct 9, 2017 and Sep 29, 2026 — classified as 6 deaths, 805 injuries, 891 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (706 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 Problem713
- Device Dislodged or Dislocated706
- Ambient Noise Problem93
- Failure to Capture86
- High Capture Threshold74
- High impedance52
- Device Sensing Problem35
- Fracture29
Patient problems
- No Clinical Signs, Symptoms or Conditions669
- Unspecified Infection585
- No Known Impact Or Consequence To Patient245
- Pocket Erosion67
- Twiddlers Syndrome46
- Cardiac Perforation14
- Endocarditis13
- Implant Pain12
Recent adverse event reports
The 25 most recent of 1,702 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Patient Device Interaction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940891 ↗InjurySep 28, 2026Device Dislodged or Dislocated
This lead was repositioned due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916369 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
System explanted due to pocket erosion. Should additional information be received, this file will be updated.
Patient problems: Pocket Erosion
MAUDE report 50899157 ↗InjurySep 23, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement. Should additional information become available, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870617 ↗InjurySep 16, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement. Should additional information become available, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794168 ↗InjurySep 16, 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 50788205 ↗InjurySep 15, 2026Device Dislodged or Dislocated
Lead dislodged shortly after implant procedure was completed. After dislodgement was discovered, patient developed pericardial effusion. MD opted to explant the lead and replace with a different type of lead. Should additional information be received this file will be updated.
Patient problems: Pericardial Effusion
MAUDE report 50773265 ↗InjurySep 15, 2026Failure to Capture; Device Sensing Problem; Impedance Problem
This lead was explanted due to loss of capture, sensing and impedance issues. 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 50772447 ↗InjurySep 11, 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 50735010 ↗InjurySep 11, 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 50734847 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50682759 ↗InjurySep 8, 2026Fracture; Ambient Noise Problem
This lead was capped due to noise and suspected insulation damage. 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 50670145 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to Vegetation noted in Echocardiogram of RV lead. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50590285 ↗InjuryAug 19, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement as a result of patient non-compliance. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331023 ↗InjuryAug 19, 2026Device Dislodged or Dislocated
This RA 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 50330285 ↗InjuryAug 17, 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 50278577 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infected endocarditis. Should additional information be received, this file will be updated.
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50233906 ↗InjuryAug 12, 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 50230293 ↗MalfunctionAug 12, 2026Ambient Noise Problem; Device Sensing Problem
Mode switch recording transmitted to Home Monitoring shows atrial oversensing of what appears to be noise. Other recent IEGMs show a clean atrial channel. Postural testing and isometrics were recommended. Lead remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230089 ↗InjuryAug 12, 2026Fracture
Lead explanted 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 50217177 ↗InjuryAug 10, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement as a result of twiddling. Should additional information be received, this file will be updated.
Patient problems: Twiddlers Syndrome
MAUDE report 50198772 ↗InjuryAug 7, 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 50179021 ↗InjuryAug 7, 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 50178996 ↗InjuryAug 4, 2026Failure to Capture; Device Sensing Problem
This lead was explanted due to loss of sensing and no 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 50134830 ↗MalfunctionJun 25, 2026Ambient Noise Problem
NOISE IS PRESENT ON RA AND RV LEAD. ALL OTHER VALUES APPEAR WITHIN NORMAL LIMITS. PATIENT IS NONCOMPLIANT WITH FOLLOW-UPS. RULED OUT EXTERNAL PROCEDURE DURING TIME OF RECORDING. LEAD REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630548 ↗
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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