Solia JT 45Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Quick summary
This is a Biotronik Solia JT 45 pacemaker lead. Many of the 84 reports describe the lead moving out of place, and others describe infections that led to removal, high electrical thresholds, or electrical noise in recordings. There are 24 injuries and no deaths. 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
- 87
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 04035479136567), received between Mar 21, 2019 and Sep 16, 2026 — classified as 27 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (45 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
- Device Dislodged or Dislocated45
- Adverse Event Without Identified Device or Use Problem24
- Failure to Capture6
- High Capture Threshold6
- Ambient Noise Problem4
- Device Sensing Problem2
- Over-Sensing2
- Capturing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Unspecified Infection20
- No Known Impact Or Consequence To Patient15
- Wound Dehiscence2
- Cardiac Perforation1
- Hematoma1
- Pain1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
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 50789561 ↗InjurySep 8, 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 50671263 ↗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 50590291 ↗MalfunctionAug 4, 2026High impedance; Ambient Noise Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136368 ↗InjuryMar 5, 2026High Capture Threshold
LEAD WAS CAPPED DUE TO ELEVATED THRESHOLDS REQUIRING HIGHER OUTPUT. 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 24515870 ↗InjuryJan 20, 2026Unstable Capture Threshold
THIS LEAD WAS CAPPED DUE TO CAPTURE WAS AT 7 VOLTS AT 1.0 MS. 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 24120051 ↗MalfunctionDec 31, 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 23933753 ↗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 23694554 ↗MalfunctionNov 25, 2025Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem
A HIGH ATRIAL RATE RECORDING ON (B)(6) 2025 SHOWS A NOISY BASELINE AND POTENTIAL OVERSENSING. LEAD EVALUATION SHOWED NORMAL FUNCTION AND NO NOISE COULD BE RECREATED. LEAD REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647961 ↗MalfunctionNov 10, 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 23509961 ↗MalfunctionOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
SLACK PULLED BACK AND LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23431218 ↗MalfunctionOct 16, 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 23312014 ↗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 22790214 ↗InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO HEMATOMA DEVELOPED POST IMPLANT, THEN WOUND DEHISCENCE DEVELOPED. POCKET TISSUE WAS SENT TO LAB TO CHECK FOR INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence
MAUDE report 22734119 ↗MalfunctionJul 16, 2025Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated
LEAD WAS EXPLANTED BECAUSE IT DISLODGED RESULTING IN POOR CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22525009 ↗MalfunctionJun 26, 2025Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold; Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO SUSPECTED MICRO-DISLODGEMENT CAUSING STACKED SENSING AND HIGH THRESHOLD. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341791 ↗MalfunctionJun 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS RA LEAD WAS EXPLANTED DUE TO SUSPECTED DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22154959 ↗InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21434694 ↗MalfunctionJan 28, 2025High Capture Threshold; High Capture Threshold
THIS RA 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 21259169 ↗MalfunctionJan 8, 2025Failure to Capture; Failure to Capture
THIS LEAD WAS REPOSITIONED DUE TO LOSS OF CAPTURE. LEAD REMAINS IMPLANTED. 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 21106132 ↗MalfunctionJan 8, 2025Ambient Noise Problem; Impedance Problem; Ambient Noise Problem; Impedance Problem
BIPOLAR LEAD FAILURE WAS RECORDED ON THE HMSC ON (B)(6) 2024. IN THE DAYS LEADING UP TO THIS, THE PACING IMPEDANCE HAD TRENDED UP. NOISE CAN ALSO BE SEEN CAUSING INAPPROPRIATE MODE SWITCH. NOISE COULD BE RECREATED IN PERSON ON (B)(6) 2024 WITH POCKET MANIPULATION. ALL IMPEDANCE VALUES WERE IN RANGE WHEN TESTED ON (B)(6) 2024. LEAD REMAINS IMPLANTED. 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 21106128 ↗MalfunctionJan 6, 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 21079399 ↗MalfunctionJul 15, 2024Failure to Capture; Failure to Capture
NO CAPTURE POST IMPLANT. LEAD WAS REPOSITIONED AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19747222 ↗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 19337520 ↗MalfunctionApr 24, 2024Device Dislodged or Dislocated; Device 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 19177358 ↗
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.