Solia S 53 377177Recalls & 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 53 pacemaker lead is a wire that connects a pacemaker to the heart. Many reports describe the lead moving out of position or infections, and some say the lead or system was removed from the patient. Some mention a puncture of the heart wall. The 3,787 reports mention 17 deaths and 1,819 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
- 3,813
- Deaths reported
- 17
- Injuries reported
- 1,843
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,813 adverse event reports that list this exact device (DI 04035479118266), received between Jun 15, 2018 and Sep 30, 2026 — classified as 17 deaths, 1,843 injuries, 1,953 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1,515 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 Problem1,591
- Device Dislodged or Dislocated1,515
- High Capture Threshold244
- Failure to Capture187
- Ambient Noise Problem133
- High impedance120
- Device Sensing Problem76
- Fracture68
Patient problems
- No Clinical Signs, Symptoms or Conditions1,545
- Unspecified Infection1,307
- No Known Impact Or Consequence To Patient514
- Pocket Erosion91
- Twiddlers Syndrome89
- Cardiac Perforation66
- Endocarditis39
- Perforation27
Recent adverse event reports
The 25 most recent of 3,813 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: Cardiac Perforation
MAUDE report 50954940 ↗InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954939 ↗InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954938 ↗InjurySep 29, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement resulting in perforation into lung. Should additional information be received, this file will be updated.
Patient problems: Internal Organ Perforation
MAUDE report 50932649 ↗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 50916372 ↗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 50916278 ↗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 50916277 ↗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 50915662 ↗MalfunctionSep 25, 2026Ambient Noise Problem
Noise appeared on RV impedance recording. All RA diagnostics appeared normal. Device 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 50899673 ↗InjurySep 25, 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 50899667 ↗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 50899158 ↗InjurySep 24, 2026Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold
This lead was explanted due to dislodgement resulting in low sensing and elevated threshold. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889996 ↗InjurySep 24, 2026Failure to Capture
RR lead was explanted due to non-capture. 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 50886301 ↗InjurySep 21, 2026Failure to Capture; Failure to Sense
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848369 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50811929 ↗InjurySep 16, 2026Device Dislodged or Dislocated; Unstable Capture Threshold
This lead was capped due to threshold issues and dislodgement. 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 50790080 ↗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 50788376 ↗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 50788233 ↗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 50787339 ↗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 50783361 ↗InjurySep 15, 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 50778908 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient developed pericardial effusion after implant. The lead was explanted and replaced with a passive lead. Should additional information be received this file will be updated.
Patient problems: Pericardial Effusion
MAUDE report 50773264 ↗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 50772564 ↗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 50735008 ↗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 50734094 ↗
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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