Solia T 60Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Solia T 60 is a drug-eluting pacemaker lead (electrode) placed in the heart's right ventricle or atrium. The 75 reports mostly describe leads that move out of position, fail to capture or sense the heartbeat, or show high electrical resistance; several mention infection that led to removing the system. There is 1 death and 27 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
- 74
- Deaths reported
- 1
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 04035479118297), received between May 8, 2019 and Jun 15, 2026 — classified as 1 death, 26 injuries, 47 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 Problem26
- Device Dislodged or Dislocated19
- High Capture Threshold12
- High impedance9
- Failure to Capture8
- Break4
- Low impedance3
- Ambient Noise Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Unspecified Infection22
- No Known Impact Or Consequence To Patient12
- Perforation2
- Asystole1
- Cardiac Perforation1
- Chest Pain1
- Death1
Recent adverse event reports
The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 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 25512525 ↗InjuryMar 23, 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 24661546 ↗MalfunctionNov 19, 2025Low impedance; Device Sensing Problem; Low impedance; Device Sensing Problem
THE LEAD WAS SUCCESSFULLY IMPLANTED, AND INITIAL BIPOLAR MEASUREMENTS WERE WITHIN ACCEPTABLE PARAMETERS. AFTER THE DEVICE WAS SUTURED IN PLACE AND THE PATIENT WAS CLOSED, SUBSEQUENT TESTING REVEALED THE ABSENCE OF BIPOLAR MEASUREMENTS, NO SENSING, AND IMPEDANCE READINGS BELOW 100 OHMS. UNIPOLAR MEASUREMENTS REMAINED ACCEPTABLE; HOWEVER, THE IMPLANTING PHYSICIAN DETERMINED THAT A NEW LEAD WAS REQUIRED. THE LEAD WAS EXPLANTED. 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 23600731 ↗InjuryOct 28, 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 23402144 ↗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 23063085 ↗MalfunctionJul 8, 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 22443781 ↗MalfunctionJun 5, 2025High impedance; High impedance
LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE NOTED GREATER THAN 2K OHMS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22154691 ↗InjuryDec 5, 2024Adverse 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 20853950 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A HEMATOMA AND INFECTION. SYSTEM WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Hematoma; Unspecified Infection
MAUDE report 20557559 ↗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 20089910 ↗MalfunctionApr 25, 2024High Capture Threshold; High Capture Threshold
THIS LEAD WAS SUCCESSFULLY REPOSITIONED THE DAY AFTER IMPLANT DUE TO THRESHOLD INCREASED TO 5.8 VOLTS AT 0.4 MS. POSSIBLY DUE TO PATIENT ANATOMY POST MITRAL VALVE REPAIR. 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 19182985 ↗MalfunctionApr 24, 2024Device 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 19177201 ↗InjuryApr 15, 2024Adverse 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 19112408 ↗InjuryMar 25, 2024Adverse 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 18975990 ↗MalfunctionFeb 27, 2024Device 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 18793817 ↗MalfunctionDec 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS RV 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 18410248 ↗InjuryDec 12, 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 18314559 ↗MalfunctionSep 12, 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 17730691 ↗MalfunctionJul 11, 2023Break; Ambient Noise Problem; High Capture Threshold; Break; Ambient Noise Problem; High Capture Threshold
THIS RV LEAD WAS EXPLANTED DUE TO NOISE AND THRESHOLDS GREATER THAN 2500 OHMS LIKELY CAUSED BY SUBCLAVIAN CRUSH. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300504 ↗MalfunctionJan 11, 2023Break; Failure to Capture; Impedance Problem; Break; Failure to Capture; Impedance Problem
LEAD WAS CAPPED DUE TO POSSIBLE INSULATION DAMAGE, DROP IN IMPEDANCE VALUES AND POSSIBLE LOSS OF CAPTURE. 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 16141407 ↗InjuryOct 19, 2022Adverse 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 15631471 ↗InjuryOct 18, 2022Adverse 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 15620954 ↗MalfunctionOct 3, 2022Fracture; High impedance; Fracture; High impedance
THIS LEAD WAS CAPPED DUE TO SUSPICION OF FRACTURE. BOTH BIPOLAR AND UNIPOLAR IMPEDANCES HIGHER THAN 2900-3000. 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 15533114 ↗MalfunctionAug 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD EXPLANTED DUE TO MICRODISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15223948 ↗MalfunctionJul 29, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold
IT WAS REPORTED THAT PACING IMPEDANCE WAS TOO HIGH AND OUT OF RANGE AND THE PACING THRESHOLDS INCREASED. THE LEAD WAS EXPLANTED AND REPLACED APPROX. 38 MONTHS AFTER THE IMPLANTATION. PLEASE NOTE THAT THE INCIDENT WAS ALREADY REPORTED BY THE HEALTH FACILITY. THE SERIAL NUMBER IN THAT REPORT WAS MISTAKEN. SOLIA T 60, SN 8000428942 WAS IMPLANTED DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15127346 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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