Solia CSP S 60 468460Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04035479177041), received between Apr 20, 2026 and Sep 30, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated10
- Adverse Event Without Identified Device or Use Problem9
- High Capture Threshold2
- Intermittent Capture1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Unspecified Infection6
- Cardiac Perforation4
- Endocarditis1
Recent adverse event reports
The 21 most recent of 21 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 50951325 ↗InjurySep 28, 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 50915958 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to endocarditis. Should additional information be received, this file will be updated.
Patient problems: Endocarditis
MAUDE report 50915665 ↗InjurySep 25, 2026High Capture Threshold
This lead was explanted due to High 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 50899795 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
This lead was attempted not implanted. Lead went through septum after slitting. Should additional information become available, this file will be updated.
Patient problems: Cardiac Perforation
MAUDE report 50870619 ↗InjurySep 11, 2026Device Dislodged or Dislocated
This lead was capped due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734313 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Perforation
MAUDE report 50599659 ↗InjurySep 3, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599383 ↗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 50568533 ↗InjurySep 1, 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 50550150 ↗InjuryAug 31, 2026Intermittent Capture; Device Dislodged or Dislocated
This lead was explanted due to dislodgement resulting in intermittent capture at max output. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50527634 ↗InjuryAug 26, 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 50456820 ↗InjuryAug 19, 2026Device Dislodged or Dislocated
Lead was attempted but not implanted due to dislodgement resulting in Perforation. Should additional information be received this file will be updated.
Patient problems: Cardiac Perforation
MAUDE report 50331024 ↗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 50278793 ↗InjuryAug 7, 2026High Capture Threshold
Lead implanted on (b)(6). On (b)(6), increased RV threshold, but lead did not look dislodged on CXR. During revision lead helix found to be bent to the left on fluoro, confirmed when lead removed and examined.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50179427 ↗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 50179014 ↗InjuryAug 6, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement resulting in the lead going through the septum into the left ventricular chamber. Should additional information be received this file will be updated.
Patient problems: Cardiac Perforation
MAUDE report 50164175 ↗InjuryJun 1, 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 25354367 ↗InjuryMay 21, 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 25249757 ↗InjuryMay 18, 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 25211102 ↗InjuryApr 20, 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 24932187 ↗
Other Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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