Solia T 53Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This Biotronik Solia T 53 is a drug-eluting wire (lead) implanted in the heart to keep a pacemaker working in the right ventricle or right atrium. The 50 reports mostly describe leads that shift out of position or break, along with higher-than-expected pacing thresholds that led to the lead being capped or removed. Twenty-three reports describe injuries and none describe deaths; infection at the implant site and pain are also mentioned. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 04035479118280), received between May 16, 2019 and Sep 29, 2026 — classified as 27 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 Problem21
- Device Dislodged or Dislocated19
- High Capture Threshold8
- Failure to Capture5
- Fracture3
- High impedance3
- Migration or Expulsion of Device2
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Unspecified Infection18
- No Known Impact Or Consequence To Patient5
- Pain2
- Fall1
- Pocket Erosion1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Capture; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926839 ↗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 50794175 ↗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 50788817 ↗InjurySep 15, 2026Entrapment of Device
Lead was attempted but it was unable to be removed due to possible entanglement on sub valvular structure so it was capped and another lead placed successfully. Lead remains inactive in the body.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778705 ↗InjuryMay 13, 2026High Capture Threshold
LEAD WAS CAPPED DUE TO HIGH RV LEAD 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 25162363 ↗InjuryMay 5, 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 25085677 ↗InjuryFeb 17, 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 24372667 ↗InjuryFeb 16, 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 24344089 ↗MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device 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 23871812 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED AND LEADS WERE CAPPED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23694458 ↗MalfunctionOct 15, 2025Device Dislodged or Dislocated; Device 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 23286141 ↗InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 23063048 ↗MalfunctionSep 5, 2025Failure to Capture; Migration or Expulsion of Device; Device Dislodged or Dislocated; Failure to Capture; Migration or Expulsion of Device; Device Dislodged or Dislocated
LEAD WAS CAPPED BECAUSE IT DISLODGED AND MIGRATED RESULTING IN NO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22982505 ↗InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 22790212 ↗MalfunctionMay 8, 2025Failure to Capture; Failure to Capture
PATIENT SYMPTOMATIC AND INTERROGATION SHOWED LOSS OF CAPTURE. PATIENT IN ER FOR MONITORING. DEVICE OUTPUTS PROGRAMMED TO HIGHER OUTPUT AND SAFETY MARGIN. IMPEDANCE MEASUREMENTS VARIED FROM 600-1400OHMS SINCE IMPLANT. X-RAY APPEARED NORMAL. DEVICE WILL BE MONITORED IN HOSPITAL AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21986696 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 21754643 ↗MalfunctionFeb 12, 2025Fracture; Fracture
THIS LEAD WAS 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 21368609 ↗MalfunctionOct 29, 2024Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated
LEAD WAS EXPLANTED DUE TO DISLODGEMENT AND MIGRATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20557451 ↗MalfunctionAug 8, 2024Fracture; High impedance; Fracture; High impedance
POSSIBLE LEAD FRACTURE. IMPEDANCE OVER 2000. THE LEAD WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945338 ↗InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. EXPLANT DATE UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 19337522 ↗MalfunctionApr 18, 2024High Capture Threshold; High Capture Threshold
PATIENT PRESENTED TO ER AFTER FALL AND ON TELEMETRY IT WAS NOTED HIS HEART RATE WAS IN THE 30S. INTERROGATION REVEALED HIGH THRESHOLD IN RV LEAD IN BIPOLAR AND UNIPOLAR. PATIENT UNDERWENT RV REPOSITION. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Fall
MAUDE report 19132928 ↗MalfunctionApr 3, 2024Device Dislodged or Dislocated; Device 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 19032904 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 18975993 ↗MalfunctionJan 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS CAPPED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18528373 ↗MalfunctionNov 21, 2023High Capture Threshold; High Capture Threshold
THIS RV LEAD WAS CAPPED DUE TO HIGH 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 18183464 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.