Solia JT 53Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
All models of Solia (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Solia JT 53 is an implanted pacemaker lead for the right ventricle or right atrium. Most of the 69 reports describe the lead moving out of position in the chest, sometimes so the pacemaker loses its grip on the heart and the lead has to be repositioned or taken out, along with some leads that stop capturing or picking up signals properly. Reports also mention infection at the implant site, fever, and wound problems. 1 death and 23 injuries were reported. 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
- 67
- Deaths reported
- 1
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 04035479132606), received between Mar 27, 2019 and Aug 18, 2026 — classified as 1 death, 21 injuries, 45 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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
- Device Dislodged or Dislocated28
- Adverse Event Without Identified Device or Use Problem20
- High Capture Threshold10
- High impedance3
- Ambient Noise Problem2
- Failure to Sense2
- Impedance Problem2
- Under-Sensing2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Unspecified Infection16
- No Known Impact Or Consequence To Patient15
- Fever2
- Wound Dehiscence2
- Bacterial Infection1
- Cardiac Perforation1
- Cardiac Tamponade1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 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 50311145 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24115212 ↗MalfunctionOct 21, 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 23346424 ↗InjurySep 16, 2025Adverse 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.
Patient problems: Unspecified Infection
MAUDE report 23063086 ↗MalfunctionJul 24, 2025High Capture Threshold; High Capture Threshold
THIS LEAD WAS REPOSITIONED DUE TO HIGH THRESHOLD AND X-RAY SHOWS SLACK PULLED BACK FROM RA LEAD. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22593910 ↗MalfunctionFeb 28, 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 21492437 ↗MalfunctionOct 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD DISLODGED DUE TO PATIENTS ANATOMY AND WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20468098 ↗InjuryAug 28, 2024Adverse 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 20089825 ↗MalfunctionAug 1, 2024High Capture Threshold; High Capture Threshold
LEAD WAS REPOSITIONED DUE TO HIGH THRESHOLD. IT REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19888518 ↗MalfunctionJul 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD WAS EXPLANTED DUE TO DISLODGMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19726456 ↗MalfunctionMay 14, 2024Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT CAUSING HIGH THRESHOLD. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19317039 ↗MalfunctionJan 29, 2024Device Sensing Problem; High Capture Threshold; Device Sensing Problem; High Capture Threshold
LEAD WAS EXPLANTED DUE TO POOR SENSING AND THRESHOLD WAS HIGH. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603296 ↗MalfunctionSep 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ENTIRE SYSTEM EXTRACTED AFTER LEADS DISLODGED AND PATIENT DIDN'T WANT SYSTEM ANYMORE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17780720 ↗MalfunctionAug 7, 2023Device 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 17471099 ↗InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse 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 16953531 ↗MalfunctionFeb 6, 2023Device 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 16304165 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OPEN WOUND. SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 15506941 ↗MalfunctionAug 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ATRIAL LEAD DISLODGEMENT. IT WAS CONFIRMED THAT THE ATRIAL LEAD WAS DOWN TO THE T VALVE. A NEW SCREW LEAD WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15180785 ↗MalfunctionJul 1, 2022Failure to Sense; Ambient Noise Problem; Failure to Sense; Ambient Noise Problem
VERY SMALL SENSING AMPLITUDE AND NOISE SEEN ON RA SIGNAL ON HMSC RECORDINGS. PATIENT WAS BROUGHT TO OFFICE AND DEVICE WAS INTERROGATED. NO SENSING SEEN IN RA TINED LEAD. SENSING IN THE RA WAS TURNED ALL THE WAY DOWN TO .2. DEVICE WAS PROGRAMMED VVI. DEVICE 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 14885911 ↗InjuryJun 16, 2022Adverse 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.
Patient problems: Unspecified Infection
MAUDE report 14714395 ↗MalfunctionJun 13, 2022Impedance Problem; Impedance Problem
RV LEAD WAS EXPLANTED AND REPLACED DUE TO BIPOLAR LEAD FAILURE REPORTED VIA HOME MONITORING. IN OFFICE PROVOCATIVE TESTING SHOWED NO ISSUES BUT THE LEAD FAILURE ALERTS KEPT COMING UP VIA HOME MONITORING. 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 14681756 ↗InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT SUFFERED FROM CHEST PAIN, PERICARDIAL EFFUSION AND WAS DIAGNOSED WITH CARDIAC TAMPONADE DUE TO PACEMAKER LEAD PERFORATION. FURTHERMORE, A INFECTION WAS SUSPECTED. THE PATIENT WAS HOSPITALIZED. FOR DIAGNOSTICS ECG, CHEST X-RAY, PULMONARY CT ANGIOGRAPHY ECHOCARDIOGRAM WAS DONE. PERICARDIOCENTESIS WAS DONE AND PERICARDIAL DRAINAGE WAS PLACED. THE PACEMAKER WAS EXPLANTED AND A NEW SYSTEM IMPLANTED. LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion
MAUDE report 14174763 ↗InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS HOSPITALIZED AFTER DEVICE IMPLANTATION AND ON (B)(6) 2022, THE CE AT THE FACILITY INFORMED THE PHYSICIAN THAT THERE WAS A SUSPICION OF INFECTION AND THAT TREATMENT MIGHT BE REQUIRED. THE PATIENT HAD NO FEVER OR WOUND PAIN, BUT THE IMPLANTED PACEMAKER BODY AND PART OF THE LEAD WERE EXPOSED FROM THE SKIN.?SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 14147649 ↗InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT SUFFERED FROM REDNESS AND SWELLING (INFECTION) AT THE PACEMAKER IMPLANTATION SITE.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 13972592 ↗MalfunctionMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED AND REPLACED THE DAY AFTER IMPLANT DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13945751 ↗
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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