Solia S 60 377179Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Solia S pacing lead is a wire that carries pacemaker pulses to the heart. Of its 1,746 reports, many describe the lead moving out of place, pulses failing to make the heart beat, and electrical noise. The reports include 6 deaths and 785 injuries, and some mention infection, a puncture of the heart and pocket erosion. 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
- 1,761
- Deaths reported
- 6
- Injuries reported
- 795
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,761 adverse event reports that list this exact device (DI 04035479118273), received between Jun 15, 2018 and Sep 30, 2026 — classified as 6 deaths, 795 injuries, 960 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (622 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem638
- Device Dislodged or Dislocated622
- Failure to Capture185
- High Capture Threshold172
- High impedance72
- Ambient Noise Problem65
- Fracture48
- Break43
Patient problems
- No Clinical Signs, Symptoms or Conditions840
- Unspecified Infection503
- No Known Impact Or Consequence To Patient178
- Cardiac Perforation57
- Twiddlers Syndrome34
- Pocket Erosion28
- Endocarditis17
- Perforation15
Recent adverse event reports
The 25 most recent of 1,761 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955016 ↗InjurySep 30, 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 50944487 ↗InjurySep 29, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940806 ↗MalfunctionSep 29, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940690 ↗InjurySep 25, 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 50899525 ↗InjurySep 24, 2026Break
Patient needed Tricuspid valve repair that required removing the lead. During the extraction the distal tip up to the ring electrode broke off and is still implanted. Should additional information be received this file will be updated.
Patient problems: Foreign Body In Patient
MAUDE report 50886446 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50811787 ↗MalfunctionSep 16, 2026Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793395 ↗MalfunctionSep 16, 2026Ambient Noise Problem; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790083 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to bacteremia. Should additional information be received, this file will be updated.
Patient problems: Bacteremia
MAUDE report 50788234 ↗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 50787237 ↗InjurySep 16, 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 50783196 ↗InjurySep 16, 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 50783130 ↗InjurySep 15, 2026High impedance
This lead was capped due to impedance trending higher and higher. No adverse patient events reported. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778906 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
System explanted due to infection. Should additional information be received this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50772646 ↗InjurySep 11, 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 50734317 ↗InjurySep 11, 2026Device Dislodged or Dislocated; Unstable Capture Threshold
Lead was explanted because it dislodged resulting in deterioration of pacing and sensing thresholds. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734316 ↗MalfunctionSep 8, 2026Ambient Noise Problem
HMSC reported nsT episode that showed possible noise. Advised further lead evaluation. Lead currently remains implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671261 ↗InjurySep 3, 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 50590284 ↗InjurySep 2, 2026Device Dislodged or Dislocated; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569220 ↗MalfunctionSep 2, 2026High impedance; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569125 ↗InjurySep 2, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569123 ↗InjurySep 2, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569121 ↗InjurySep 2, 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 50568845 ↗InjuryAug 31, 2026Ambient Noise Problem
Lead was capped and replaced with new lead due to 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 50527639 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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