Optisense™ 1999-46Recalls & reported problems

Summary

The FDA's MAUDE database contains 521 adverse event reports that list this exact device (DI 05414734502474), received between Jun 12, 2018 and Aug 27, 2026 — classified as 17 deaths, 253 injuries, 251 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (231 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 521 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Over-Sensing; Use of Device Problem

  It was reported that the patient presented to the hospital for a scheduled generator exchange procedure. Interrogation of the pulse generator noted multiple atrial tachycardia/atrial fibrillation (AT/AF) episodes due to the right atrial (RA) lead noise over-sensing. During the procedure, fluoroscopy performed showed that the RA lead and the right ventricular (RV) leads slack had been significantly removed. The RA lead was explanted and replaced, and the RV lead's slack was revised, and the lead was reconnected to the new pulse generator. The patient was stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50467755 ↗
• MalfunctionAug 20, 2026Over-Sensing; Pacing Problem

  It was reported that the patent¿s right atrial (RA) lead exhibited oversensing noise resulting in inappropriate mode switch. In clinic isometric exercise and lead revision were suggested, no change or intervention was reported. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50336204 ↗
• InjuryJun 22, 2026Failure to Disconnect

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON DEVICE INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED NOISE OVERSENSING, WHICH RESULTED IN PACING INHIBITION. THE PATIENT WAS EVALUATED UNDER FLUOROSCOPY, WHICH DID NOT REVEAL ANY OBSERVABLE LEAD DAMAGE; HOWEVER, IT WAS NOTED THAT THE RV AND ATRIAL LEADS WERE ADHERED TOGETHER. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED BOTH THE RV AND ATRIAL LEADS. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573885 ↗
• MalfunctionJun 3, 2026Over-Sensing

  IT WAS NOTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE OVERSENSING. THE PROGRAMMING CHANGES WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386546 ↗
• InjuryMay 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH PACING IMPEDANCE AND LEAD INTEGRITY ISSUE WAS SUSPECTED. MILD VALVULAR REGURGITATION WAS NOTED. THE ATRIAL LEAD SHOWED OVERSENSING DUE TO NOISE. BOTH LEADS WERE CAPPED ON (B)(6) AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 25208905 ↗
• MalfunctionMay 16, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT OVERSENSING DUE TO NOISE, AND INAPPROPRIATE AUTO MODE SWITCHING (AMS) WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD AS WELL AS COMPETITIVE ATRIAL PACING. PROGRAMMING CHANGES WERE RECOMMENDED. THE PHYSICIAN OPTED TO MONITOR IN CASE OF RE-OCCURRENCE. THE PATIENT WAS ASYMPTOMATIC AND THERE HAD BEEN NO COMPLAINTS OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25195229 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A POCKET REVISION, COMPLAINING OF DISCOMFORT NEAR THE PACEMAKER HEADER AND COILED LEADS. THE PHYSICIAN DETERMINED THAT THE LEADS POSITIONED LATERAL TO THE DEVICE POCKET WERE NOT THE CAUSE OF DISCOMFORT. DURING THE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN VISUALLY NOTED A POSSIBLE PARTIAL INSULATION BREACH ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BUT ELECTED NOT TO REPAIR THEM. A NEW DEVICE POCKET WAS CREATED MORE MEDIALLY, AND THE PACEMAKER, RA AND RV LEADS REMAINED CONNECTED AND IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134030 ↗
• InjuryMay 8, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC. IT WAS NOTED THAT THE RIGHT ATRIAL LEAD EXHIBITED UNDER-SENSING AND COULD NOT PICK UP ANY P WAVES. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25120534 ↗
• InjuryApr 29, 2026Signal Artifact/Noise; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC VIA MERLIN.NET TRANSMISSION. REVIEW OF THE TRANSMISSION INDICATED THAT THE RIGHT ATRIAL (RA) LEAD DEMONSTRATED NOISE, LOW PACING IMPEDANCE, AND UNDERSENSING, WHICH RESULTED IN INACCURATE ARRHYTHMIA REPORTING. THE PATIENT WAS SUBSEQUENTLY BROUGHT INTO THE CLINIC, WHERE THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RA LEAD ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024615 ↗
• MalfunctionApr 23, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE. IN CLINIC LEAD TESTING WAS SUGGESTED; NO CHANGES OR INTERVENTION WERE DONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974670 ↗
• InjuryApr 23, 2026Signal Artifact/Noise; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE PROCEDURE. UPON INTERROGATION, THE ATRIAL LEAD EXHIBITED NOISE EPISODES. FURTHER VISUAL EXAMINATION, INSULATION DAMAGE WAS OBSERVED. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967826 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. THE PATIENT'S RIGHT VENTRICULAR LEAD, THE RIGHT ATRIAL LEAD AND THE LEFT VENTRICULAR LEADS WERE ALSO NOTED TO HAVE ERODED. THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR ALONG WITH THE RIGHT VENTRICULAR LEAD, THE RIGHT ATRIAL LEAD AND THE LEFT VENTRICULAR LEADS WERE EXPLANTED DUE TO INFECTION. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 24880062 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN EROSION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), RIGHT VENTRICULAR LEAD, AND ATRIAL LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 24849294 ↗
• InjuryApr 2, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. TRANSMISSION SHOWED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761830 ↗
• MalfunctionMar 31, 2026Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT CAPTURE. REASSESSMENT OF CAPTURE WAS SUGGESTED; NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750491 ↗
• MalfunctionMar 17, 2026Over-Sensing; Pacing Problem; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLD, VARIATION IN SENSING AND NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24614562 ↗
• InjuryMar 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566203 ↗
• InjuryFeb 4, 2026Over-Sensing; Pacing Problem; Failure to Sense

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. THE NOISE WAS REPRODUCIBLE WITH PHYSICAL MOVEMENT. THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255516 ↗
• InjuryFeb 3, 2026Signal Artifact/Noise; Over-Sensing; Failure to Disconnect

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. AN X-RAY WAS PERFORMED, AND THE PHYSICIAN NOTED THAT THE RA LEAD APPEARED TO BE STUCK TO THE RV LEAD. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RA LEAD HOWEVER, SOME PARTS OF THE LEAD COULD NOT BE FULLY EXTRACTED AND WERE LEFT IN THE BODY. THE RV LEAD EXPLANTED AND REPLACED THAT SAME DAY. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249761 ↗
• MalfunctionJan 27, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THROUGH REMOTE TRANSMISSION THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD WAS OVER-SENSING NOISE RESULTED IN INAPPROPRIATE MODE SWITCH EPISODES. PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196384 ↗
• MalfunctionJan 12, 2026Failure to Disconnect

  IT WAS REPORTED DURING UNRELATED RIGHT VENTRICULAR (RV) LEAD REVISION THAT THE ATRIAL LEAD WAS ADHERED TO THE RV LEAD AND HAD TO BE EXPLANTED WITH IT. THE ATRIAL LEAD WAS SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24045888 ↗
• MalfunctionDec 26, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  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 AND LED TO AN INAPPROPRIATE AUTOMATIC MODE SWITCH. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WOULD CONTINUE TO BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894787 ↗
• InjuryNov 27, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A SCHEDULED FOLLOW UP. INTERROGATION SHOWED THAT THERE WERE AUTOMATIC MODE SWITCH (AMS) EPISODES FROM NOISE OVER-SENSING ON THE RIGHT ATRIAL (RA) LEAD. THE NOISE WAS REPRODUCIBLE VIA ISOMETRIC TEST. THE RA LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663625 ↗
• MalfunctionNov 26, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVER SENSED NOISE AND DELIVERED INAPPROPRIATE SHOCK. THE PATIENT REPORTED SYMPTOMS OF TIREDNESS AND FEELING OVERWHELMED. ADDITIONALLY, ATRIAL LEAD NOISE WAS NOTED. PROGRAMMING CHANGES WERE MADE TO RESOLVE OVER-SENSING ISSUE ON ICD, AND NO INTERVENTION WAS PERFORMED FOR ATRIAL LEAD NOISE. PATIENT CONDITION WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 23659792 ↗
• MalfunctionNov 26, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  NEW INFORMATION RECEIVED NOTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION NOTED THAT THE RIGHT ATRIAL (RA) NOISE EXHIBITED OVERSENSING NOISE RESULTED IN INAPPROPRIATE MODE SWITCH. PROGRAMMING CHANGES ON THE SENSITIVITY WERE MADE IN CLINIC. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653611 ↗