Optisense™ 1999-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 05414734502467), received between Jul 25, 2018 and Feb 5, 2026 — classified as 2 deaths, 17 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (15 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A VALVE REPLACEMENT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. POST-PROCEDURE, IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNSPECIFIED CAPTURE ISSUE. THE RV LEAD AND RA LEAD WERE CAPPED ON (B)(6) 2026. THE EXISTING PACEMAKER WAS EXPLANTED AND REPLACED WITH AN AVEIR DR SYSTEM. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271919 ↗
• InjuryOct 15, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING THAT CAUSED HIGH ATRIAL RATE EVENTS. THE RA LEAD WAS CAPPED AND REPLACED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306924 ↗
• MalfunctionJan 14, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE. NO INTERVENTION WAS PERFORMED. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509916 ↗
• MalfunctionNov 22, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT BLOOD FLOWING BACK OUT OF THE PROXIMAL OPENING OF THE RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS NOT USED. THE PHYSICIAN CONTINUED WITH SECOND RA LEAD AND COMPLETED THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18189272 ↗
• MalfunctionAug 23, 2023Break; Difficult to Fold, Unfold or Collapse; High impedance; Capturing Problem; Break; Difficult to Fold, Unfold or Collapse; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. DURING THE IMPLANT IT WAS NOTED THAT THE RIGHT ATRIAL LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH IMPEDANCE. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD; HOWEVER, THE HELIX WOULD NOT EXTEND. IT WAS SUSPECTED THAT THE LEAD WAS BROKEN CAUSING THE IMPEDANCE TO RISE AND HELIX NOT TO EXTEND. THE LEAD WAS NOT USED, AND A NEW LEAD WAS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605248 ↗
• MalfunctionJul 24, 2023Break; Break

  RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-36583. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR POCKET REVISION. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED DISCOMFORT DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING POCKET REVISION PROCEDURE, IT WAS ALSO FOUND THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INSULATION BREACH. THE ICD WAS REPOSITIONED, AND THE RA LEAD WAS REPAIRED ON (B)(6) 2023. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385926 ↗
• InjuryJul 20, 2023Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  NEW INFORMATION RECEIVED NOTED THAT THE RIGHT ATRIAL (RA) LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17358557 ↗
• MalfunctionMar 22, 2023Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16594711 ↗
• MalfunctionMar 7, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, THE RIGHT ATRIAL LEAD EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496161 ↗
• InjuryFeb 2, 2023Signal Artifact/Noise; Break; Low impedance; Signal Artifact/Noise; Break; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSIONS SHOWED THAT THE RIGHT ATRIAL LEAD EXHIBITED A LOW PACING IMPEDANCE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT'S CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281925 ↗
• MalfunctionJan 5, 2023Break; Over-Sensing; Break; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-00472. IT WAS REPORTED THAT PRIOR TO A GENERATOR CHANGE, OVERSENSING NOISE WAS OBSERVED ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE NOISE WAS NOT REPRODUCIBLE. DURING THE GENERATOR CHANGE, INSULATION DAMAGE WAS VISIBLY NOTED ON THE RA LEAD. THE PHYSICIAN USED A SUTURE SLEEVE TO PATCH THE DAMAGED INSULATION. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109262 ↗
• InjuryOct 6, 2022Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing

  RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2022-40804. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING IMPEDANCE AND PACING INHIBITION DUE TO NOISE OVER-SENSING. IT WAS ALSO FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING AND HIGH DEFIBRILLATING IMPEDANCE. IT WAS ALLEGED THAT BOTH RV LEAD AND RA LEAD WERE FRACTURED. THE RV LEAD AND RA LEAD WERE BOTH EXPLANTED AND REPLACED. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555929 ↗
• MalfunctionMar 31, 2022Over-Sensing; Pacing Problem; Low impedance; Over-Sensing; Pacing Problem; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, IT WAS DISCOVERED THAT THE RIGHT ATRIAL LEAD (RA) EXHIBITED NOISE THAT WAS OVERSENSED BY THE DEVICE AND LED TO INAPPROPRIATE MODE SWITCH. THE LEAD ALSO EXHIBITED LOW PACING IMPEDANCE. PROGRAMMING CHANGES WERE DONE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13970642 ↗
• InjuryFeb 22, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH TWIDDLERS SYNDROME. THE RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE DISLODGED. REPOSITIONING OF THE RA LEAD WAS ATTEMPTED, BUT A STYLET FAILED TO BE ADVANCED INTO THE RA LEAD. THE RA LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579045 ↗
• InjuryDec 3, 2021Over-Sensing; Pacing Problem; Low impedance; Capturing Problem; Over-Sensing; Pacing Problem; Low impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA (B)(6). REVIEW OF THE TRANSMISSION REVEALED THAT THE ATRIAL LEAD EXHIBITED LOW IMPEDANCE, HIGH THRESHOLD AND NOISE LEADING TO OVERSENSING AND TRIGGERING AUTO MODE SWITCH EPISODES. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927205 ↗
• DeathJul 12, 2021Over-Sensing; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT THE PHYSICIAN ALLEGED FIBROUS TISSUE IN-GROWTH ON THE LEAD, NOT THE LEAD ITSELF AS THE PRIMARY CAUSE OF THE REPORTED EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 12153902 ↗
• MalfunctionJul 7, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE ATRIAL LEAD TO BE IMPLANTED EXHIBITED NOISE. THE ATRIAL LEAD WAS REPLACED DURING THE SAME PROCEDURE ON (B)(6) 2021. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131330 ↗
• InjuryFeb 15, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR ROUTINE GENERATOR CHANGE WITH THE RIGHT ATRIAL LEAD EXHIBITING NOISE. THE LEAD WAS WAS CAPPED AND REPLACED ON 10 DEC 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329511 ↗
• InjuryFeb 15, 2021Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT NOISE ON THE ATRIAL LEAD WAS SEEN VIA AUTO MODE SWITCH EGM STORAGE. THE ATRIAL LEAD WAS CAPPED AND REPLACED (B)(6) 2021. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328071 ↗
• MalfunctionDec 21, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  NEW INFORMATION NOTED THAT THE ATRIAL LEAD WAS REPROGRAMMED 11 DEC 2020. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11046813 ↗
• InjuryOct 19, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WAS NOTED WITH NOISE. NO SYMPTOMS WERE REPORTED THAT CORRELATED WITH NOISE AND OVERSENSING. THE NOISE WAS REPRODUCIBLE WITH ISOMETRIC ARM MOVEMENTS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10701459 ↗
• MalfunctionJun 11, 2020Break; Break

  IT WAS REPORTED THAT DURING A DEVICE CHANGING PROCEDURE, EXTERNALIZED CONDUCTOR WAS OBSERVED ON THE ATRIAL LEAD. ATRIAL LEAD INSULATION WAS PULLED BACK TO THE SUTURE SLEEVE AREA, AND THE CONDUCTOR COIL OF THE LEAD WAS EXPOSED. THE LEAD WAS REPAIRED WITH MEDICAL ADHESIVE. THE PATIENT WAS STABLE AND BEING MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10143480 ↗
• InjuryMar 30, 2020Signal Artifact/Noise; Signal Artifact/Noise

  NEW INFORMATION RECEIVED NOTED THAT THE ATRIAL LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9898459 ↗
• InjuryDec 3, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE THAT RESULTED IN EPISODES OF ATRIAL OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2019. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9407027 ↗
• DeathOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-14995, 2938836-2019-14997. IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death

  MAUDE report 9205855 ↗