Optisense™ 1999-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,019 adverse event reports that list this exact device (DI 05414734502481), received between Jun 11, 2018 and Sep 30, 2026 — classified as 16 deaths, 467 injuries, 536 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (487 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 1,019 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951329 ↗
• MalfunctionSep 5, 2026Signal Artifact/Noise; Therapy Delivered to Incorrect Body Area

  Patient problems: Discomfort

  MAUDE report 50632303 ↗
• MalfunctionSep 3, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596936 ↗
• MalfunctionAug 21, 2026Signal Artifact/Noise

  It was reported that the patient¿s right atrial lead exhibited noise problem. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50363656 ↗
• MalfunctionAug 20, 2026High impedance

  During an unrelated procedure, an increase in pacing impedance was observed on the right atrial (RA) lead. The RA lead was capped and replaced to resolve event. No abnormalities were seen visually or via diagnostic imaging during the procedure. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50352903 ↗
• InjuryAug 20, 2026Signal Artifact/Noise

  It was reported that the patient presented for a follow-up in clinic. Interrogation revealed that the right atrial (RA) lead exhibited noise. Right ventricular (RV) lead was reported to be intact, and no trauma was observed at the site. The RA lead was capped and replaced successfully on (b)(6) 2026. The patient remained stable throughout the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334806 ↗
• InjuryJul 31, 2026Over-Sensing; Pacing Problem; Failure to Sense

  It was reported that the patient presented to the hospital for a lead revision procedure. The patient's right ventricular (RV) lead exhibited noise oversensing, resulting in inappropriate pacing in noise reversion mode, and low sensing, causing failure to sense. The RV lead was explanted and replaced with a new lead implanted in the His bundle region. The patient was stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50095102 ↗
• InjuryJul 27, 2026Break; Over-Sensing

  It was reported that, noise resulting in oversensing was noted on the right atrial (RA) lead. RA lead damage was suspected but this was not confirmed. X-ray imaging was performed; no anomalies were noted. The RA lead was capped to resolve this event. No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50012841 ↗
• InjuryMay 21, 2026Degraded; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE RESULTING IN UNDER PACING. DURING THE PROCEDURE, IT FOUND THAT THE RA LEAD HAD INSULATION DETERIORATION. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25238429 ↗
• MalfunctionMay 20, 2026Break; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT NOISE RESULTING IN OVERSENSING AND AUTOMATIC MODE SWITCH (AMS) WERE OBSERVED ON THE ATRIAL LEAD. LEAD DAMAGE WAS SUSPECTED BUT NOT CONFIRMED. NO INTERVENTION WAS PERFORMED; THE LEAD REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25229344 ↗
• InjuryMay 14, 2026Failure to Capture

  IT WAS REPORTED THAT POST-OPEN HEART SURGERY, DEVICE INTERROGATION DURING A ROUTINE FOLLOW UP REVEALED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM OUTPUT. THE PATIENT WAS SUBSEQUENTLY BROUGHT IN FOR A LEAD REVISION PROCEDURE; THE RA LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25169173 ↗
• MalfunctionMay 13, 2026Break; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT, NOISE RESULTING IN OVERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. RA LEAD DAMAGE WAS SUSPECTED BUT THIS WAS NOT CONFIRMED. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159993 ↗
• MalfunctionMay 12, 2026Over-Sensing; Pacing Problem; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC FOR A FOLLOW UP. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLD, LOW SENSING, OVERSENSING NOISE RESULTING IN INAPPROPRIATE MODE SWITCH. PROGRAMMING CHANGES WERE MADE TO ADDRESS THE ISSUES. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146094 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR BI-ATRIAL CRT-D SYSTEM EXTRACTION DUE TO INFECTION. ECHOCARDIOGRAPHY WAS PERFORMED AND REVEALED METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) INFECTION WITH UNCONFIRMED LEAD VEGETATION. THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA), LEFT ATRIAL (LA), RIGHT VENTRICULAR (RV), AND LATERAL CORONARY SINUS LEADS WERE EXPLANTED AND REPLACED WITH A NEW CONTRALATERAL CRT-D SYSTEM. THE CAUSE OF THE INFECTION WAS NOT DEFINITIVELY CONFIRMED; HOWEVER, IT WAS SUSPECTED TO BE ASSOCIATED WITH A RECENT GASTROINTESTINAL DIAGNOSTIC PROCEDURE. THE PATIENT¿S CONDITION REMAINED STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 25085475 ↗
• InjuryMay 5, 2026Break; Over-Sensing; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A GENERATOR CHANGE PROCEDURE. PRIOR TO THE PROCEDURE, DEVICE INTERROGATION IDENTIFIED ATRIAL LEAD NOISE OVERSENSING, WHICH RESULTED IN INAPPROPRIATE AUTO MODE SWITCH (AMS). THE NOISE HAD BEEN PREVIOUSLY NOTED ON STORED ELECTROGRAMS (EGMS) BUT WAS NOT REPRODUCIBLE AT THE TIME OF EVALUATION. ADDITIONALLY, THE ATRIAL LEAD DEMONSTRATED VARIABLE P-WAVE AMPLITUDE. DURING THE PROCEDURE, THE ATRIAL LEAD WAS ASSESSED, AND INSULATION DAMAGE WAS IDENTIFIED. AS A RESULT, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE ATRIAL LEAD DURING THE SAME PROCEDURE ON (B)(6) 2026. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25077130 ↗
• MalfunctionMay 3, 2026No Apparent Adverse Event

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

  Patient problems: Insufficient Information

  MAUDE report 25064112 ↗
• MalfunctionApr 28, 2026Over-Sensing; Pacing Problem; Low impedance

  DURING A FOLLOW-UP IN-CLINIC, EPISODES OF NOISE RESULTING IN OVERSENSING, DECREASE IN PACING IMPEDANCE, AND INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) WERE OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021865 ↗
• InjuryApr 28, 2026Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED FOR PROBE DRIVE PROBLEM AND THE RIGHT ATRIAL (RA) LEAD WAS CAPPED DUE TO INSULATION DAMAGE. THE RA LEAD INSULATION DAMAGE WAS CONFIRMED VIA CHEST X-RAY. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25011874 ↗
• MalfunctionApr 15, 2026Over-Sensing

  IT WAS REPORTED THAT PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DUE TO LEAD NOISE LEADING TO PACING INHIBITION. ISOMETRICS WAS PERFORMED AND LEAD NOISE ON RA AND RV WERE REPRODUCIBLE. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885010 ↗
• MalfunctionApr 6, 2026Break; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT DURING A REMOTE FOLLOW UP, NOISE RESULTING IN OVERSENSING AND INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE PHYSICIAN SUSPECTED RA LEAD DAMAGE, HOWEVER, DIAGNOSTIC IMAGING WAS NOT PERFORMED. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND REPROGRAMMING WAS RECOMMENDED. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792378 ↗
• MalfunctionMar 26, 2026Signal Artifact/Noise; Break; Low impedance

  DURING A FOLLOW-UP IN-CLINIC, EPISODES OF NOISE AND DECREASED PACING IMPEDANCE RESULTING IN ARRHYTHMIA WERE OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. RA LEAD DAMAGE WAS ALLEGED, BUT NOT CONFIRMED. REPROGRAMMING WAS PERFORMED TO RESOLVE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Arrhythmia

  MAUDE report 24707549 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. IT WAS UNKNOWN WHETHER THE INFECTION WAS CAUSED OR CONTRIBUTED TO BY THEIR IMPLANTED SYSTEM. THE ICD WAS REPLACED BY AVEIR LEADLESS PACEMAKER (LP). IT WAS LATER FOUND THAT THE CAPTURE THRESHOLD INCREASED, RESULTING IN LOSS OF CAPTURE. THE LP WAS THEN EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 24626804 ↗
• InjuryMar 13, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC. UPON INTERROGATION OF THE DEVICE, THE ATRIAL LEAD EXHIBITED NOISE OVERSENSING. THE ATRIAL LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595230 ↗
• InjuryMar 10, 2026Low impedance

  IT WAS REPORTED THAT DURING A DEVICE CHECK, BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCES WERE LOW OUT OF RANGE. BOTH OF THE LEAD IMPEDANCES WERE SUDDENLY MEASURED ABNORMALLY AT THE SAME TIME BETWEEN (B)(6) 2025. THE LAST DEVICE CHECK WAS PERFORMED IN (B)(6) 2019. NO CAPTURE WAS ALSO OBSERVED ON THE RV LEAD. THE PATIENT WAS ALSO TESTED POSITIVE FOR BACTEREMIA IN THE BLOODSTREAM UNRELATED TO THE PRODUCTS. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 24558828 ↗
• MalfunctionMar 10, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. NO INTERVENTIONS OR CHANGES WERE REPORTED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24554940 ↗