OptisenseRecalls & reported problems across all models

We found 3 models of Optisense by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,571 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 35 deaths, 737 injuries, 799 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (733 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Optisense problems

Optisense models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Optisense™ 1999-52

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  16 deaths1,019 reports
• Optisense™ 1999-46

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  17 deaths521 reports
• Optisense™ 1999-40

  Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
  2 deaths31 reports

Recent Optisense adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 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 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 ↗

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