FINELINE® II Sterox 4459Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00802526061004), received between Apr 22, 2016 and Sep 6, 2024 — classified as 48 injuries, 9 malfunctions.

The most frequently reported specific device problem is “High impedance” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED HIGH OUT OF RANGE PACING IMPENDENCE MEASUREMENTS. TECHNICAL SERVICES (TS) WAS CONSULTED, AND THE PATIENT WAS REFERRED TO THEIR CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156848 ↗
• InjuryJan 29, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD IS NOT WORKING PROPERLY. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18599099 ↗
• InjuryNov 20, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND IMPEDANCE. SUBSEQUENTLY THIS LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173100 ↗
• InjurySep 4, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH LEAD IMPEDANCE A FRACTURE WAS SUSPECTED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680497 ↗
• InjuryJul 25, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED DUE TO UNKNOWN REASONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393492 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO POCKET ABSCESS WITH INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17351917 ↗
• InjuryMar 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD'S INSULATION WAS DAMAGED. DURING GENERATOR CHANGE, THIS RV LEAD WAS NOTED TO HAVE LOST ITS INSULATION. MOREOVER, THE PATIENT ALSO EXPERIENCED BRADYCARDIA. THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS LEAD WAS EXPLANTED.

  Patient problems: Bradycardia

  MAUDE report 16592333 ↗
• InjuryMar 17, 2023Signal Artifact/Noise; Fracture; Over-Sensing; Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND OVERSENSING DUE TO A FRACTURE THAT WAS CONFIRMED VIA FLUOROSCOPY. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564611 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO THE PHYSICIAN HAVING DIFFICULTIES ACCESSING THE PATIENTS LEFT SIDE, SO THE PHYSICIAN OPTED TO IMPLANT A NEW LEAD ON THE PATIENTS RIGHT SIDE. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16419276 ↗
• InjuryJan 29, 2023Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY EXPLANTED DUE TO EXHIBITING HIGH, OUT OF RANGE PACING IMPEDANCE (GREATER THAN 3,000 OHMS), SAFETY SWITCH TO UNIPOLAR PACING, RISING THRESHOLDS, FAILURE TO CAPTURE AND NOISE. PRIOR TO BEING EXPLANTED, AN IN-OFFICE X-RAY IMAGE REVEALED THE VISUAL APPEARANCE OF THE RV LEAD TO BE INTACT. DURING THE EXPLANT PROCEDURE, WHILE PULLING BACK ON THE RV LEAD, THE TIP BROKE OFF AND DISLODGED TOWARDS THE PULMONARY ARTERY. USING A SPECIALIZED SHEET, THE TIP WAS EXTRACTED, BUT THE RING REMAINS IN PLACE, AND IS UNABLE TO BE REMOVED. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. THE RV LEAD WAS DISPOSED OF AT THE FACILITY BY THE PHYSICIAN. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261743 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940938 ↗
• InjuryOct 21, 2022Failure to Capture; High impedance; Defective Device; High Capture Threshold; Failure to Capture; High impedance; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS LEAD EXPERIENCED DAMAGE AND EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, FAILURE TO CAPTURE AND HIGH PACING THRESHOLDS. IT WAS DECIDED TO SURGICALLY ABANDON THIS LEAD. ANOTHER LEAD WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655383 ↗
• InjurySep 12, 2022Signal Artifact/Noise; Failure to Capture; Extracardiac stimulation; Defective Device; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Extracardiac stimulation; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, HIGH PACING THRESHOLD MEASUREMENTS, AND INTERMITTENT LOSS OF CAPTURE (LOC). THE NOISE WAS MORE PRONOUNCED IN THE BIPOLAR CONFIGURATION AND LESS SO IN UNIPOLAR. THE AUTOMATIC CAPTURE FEATURE MITIGATED THE INTERMITTENT LOC. ADDITIONALLY, MUSCLE/POCKET STIMULATION WAS REPORTED AND AN INSULATION ISSUE WAS SUSPECTED ON THE RV LEAD. THE PACEMAKER HAD REACHED NORMAL END OF LIFE (EOL) BATTERY STATUS, SO DURING THE DEVICE REPLACEMENT PROCEDURE, THIS RV LEAD, AND THE CHRONIC RIGHT ATRIAL (RA) LEAD, WERE SURGICALLY ABANDONED AND AN ENTIRELY NEW PACEMAKER SYSTEM WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 15407404 ↗
• MalfunctionSep 9, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE. AFTER REPROGRAMING, A WITHIN RANGE MEASUREMENT WAS OBTAINED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396808 ↗
• InjuryJul 19, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED 20 YEARS POST IMPLANT DUE TO HIGH THRESHOLD. A NEW MEDTRONIC PACEMAKER WAS IMPLANTED ON THE RIGHT SIDE WITH 2 NEW LEADS. THE ROOT CAUSE OF THE HIGH THRESHOLD WAS DETERMINED TO BE RELATED TO PATIENT'S ANATOMY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061566 ↗
• InjuryJul 13, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN PACE IMPEDANCE MEASUREMENTS UP TO AN OUT OF RANGE MEASUREMENT OF 1,803 OHMS. IT WAS NOTED THAT RV IMPEDANCE WAS 1,346 OHMS ON (B)(6) 2021. PREVIOUS IN-OFFICE THRESHOLD MEASUREMENT FROM 2019 WAS [email protected], AND NOW RV OUTPUT WAS FIXED AT [email protected]. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER LEAD EVALUATION AND CHECKING UNIPOLAR CONFIGURATION FOR POTENTIALLY BETTER LEAD MEASUREMENTS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999035 ↗
• InjuryMay 5, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291236 ↗
• InjuryMar 4, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LEAD WAS SURGICALLY ABANDONED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675481 ↗
• InjuryFeb 3, 2022Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE BOTH EXPLANTED DUE TO ISOMETRICS NOISE AND OVERSENSING. THERE WAS NO PACING INHIBITION NOTED ON EITHER LEAD. THE LEADS WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13443902 ↗
• InjuryJan 27, 2022Failure to Capture; Material Integrity Problem; Failure to Capture; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS ADMITTED TO THE HOSPITAL DUE TO SYNCOPE. INTERROGATION OF THE ASSOCIATED PACEMAKER CONFIRMED NORMAL DEVICE FUNCTION HOWEVER THE BEDSIDE CARDIAC MONITOR SHOWED LOSS OF CAPTURE (LOC). ISOMETRICS WERE UNABLE TO CREATE ANY NOISE. AN X-RAY REVELATED WHAT APPEARS TO BE CLAVICULAR FIRST RIB CRUSH. INTERVENTION IS PENDING TO REPLACE THE LEAD.

  Patient problems: Syncope/Fainting

  MAUDE report 13377549 ↗
• InjuryJan 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO INCREASING PACE IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE PATIENT WAS PACER DEPENDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226738 ↗
• InjuryJan 2, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A PACE IMPEDANCE MEASUREMENT OF GREATER THAN 3,000 OHMS, RESULTING IN A LEAD SAFETY SWITCH. THE PATIENT WAS REPORTED TO HAVE BEEN HOSPITALIZED. A RV LEAD CONDUCTOR FRACTURE WAS REPORTED. THE PATIENT WILL CONTINUE TO BE MONITORED. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13138768 ↗
• InjuryOct 12, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO LOSS OF CAPTURE. THE CAUSE OF LOSS OF CAPTURE WAS NOT DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12620245 ↗
• InjurySep 30, 2021Pacing Problem; High Capture Threshold; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO HIGH PACING THRESHOLDS AND NOT DELIVERING PACING WHEN REQUIRED. IT WAS SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551370 ↗
• InjurySep 22, 2021Signal Artifact/Noise; Over-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING. SUBSEQUENTLY, LEAD REVISION WAS PERFORMED, AND IT WAS NOTED THE OVERSENSING OF NOISE APPEARED TO BE RESOLVED POST REVISION. HOWEVER, MORE RECENTLY, THE RV LEAD EXHIBITED NOISE AND OVERSENSING ONCE AGAIN. TECHNICAL SERVICES (TS) WAS CONSULTED AND CONFIRMED THE NOISE AND OVERSENSING, AND ALSO NOTED A RECENT LEAD SAFETY SWITCH (LSS) DUE TO LOW RV PACE IMPEDANCE. INFORMATION LATER RECEIVED INDICATES THE HCP HAS SINCE DECIDED TO SEND THE PATIENT TO A DIFFERENT HOSPITAL FOR A FUTURE LEAD REPLACEMENT PROCEDURE. THE LOCAL AREA FIELD REPRESENTATIVE WAS NOT PROVIDED ANY FURTHER INFORMATION BEYOND THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514750 ↗