OPTISURE™ LDA220Q-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 05414734507349), received between Jul 2, 2018 and Mar 10, 2026 — classified as 3 deaths, 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (P950022); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Over-Sensing

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING THAT WAS RESULTING IN PACING INHIBITION. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559718 ↗
• InjuryMar 4, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD, RESULTING IN FAILURE TO CAPTURE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513168 ↗
• InjuryDec 3, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH CAPTURE THRESHOLDS AND HIGH PACING IMPEDANCE NOTES ON THE PATIENT'S RIGHT VENTRICULAR LEAD. LEAD EXTRACTION WAS PLANNED, BUT DURING THE PROCEDURE, THE LEAD WAS UNABLE TO BE EXPLANTED SINCE ACCESS WAS UNABLE TO BE OBTAINED AND WAS LEFT IN PLACE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711724 ↗
• InjuryAug 22, 2024Failure to Deliver Shock/Stimulation; Over-Sensing; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Charging Problem; Failure to Deliver Shock/Stimulation; Over-Sensing; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Charging Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN OVER CURRENT DETECTION ALERT NOTED ON THE RIGHT VENTRICULAR LEAD. OTHER ISSUES OF LOSS OF HV OUTPUT AND LOW DEFIBRILLATION IMPEDANCE. CORRECTIVE INTERVENTION WAS PLANNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034506 ↗
• MalfunctionMay 22, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH DEFIB IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378263 ↗
• MalfunctionOct 9, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT NOISE AND NON-SUSTAINED VENTRICULAR OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING CHANGES WERE MADE. FURTHER INFORMATION WAS NOT RECEIVED.

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

  MAUDE report 17900517 ↗
• InjuryFeb 9, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM. UPON REVIEW, THE RIGHT VENTRICULAR LEAD EXHIBITED OVER-SENSED NOISE LEADING TO INAPPROPRIATE SHOCK. THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. DURING THE PROCEDURE, THE RIGHT ATRIAL LEAD WAS DISLODGED. THE RIGHT ATRIAL LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-02903.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501949 ↗
• MalfunctionSep 28, 2021Signal Artifact/Noise; Break; Over-Sensing; Signal Artifact/Noise; Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DURING INTERROGATION, IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541449 ↗
• MalfunctionAug 18, 2021High impedance; High impedance

  IT WAS REPORTED IN A CLINICAL FOLLOW UP THAT THE PATIENT'S RIGHT VENTRICULAR LEAD (RV) EXHIBITED HIGH PACING IMPEDANCE. THE RV LEAD WILL BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12338035 ↗
• DeathFeb 19, 2021High impedance; Defective Device; High impedance; Defective Device

  IT WAS REPORTED THAT THE PATIENT RECEIVED A VIBRATORY ALERT AND PRESENTED IN CLINIC. UPON INTERROGATION, THE RIGHT VENTRICULAR LEAD WAS NOTED WITH HIGH, OUT OF RANGE HIGH VOLTAGE IMPEDANCE. NO INTERVENTION WAS MADE, AND THE PATIENT WAS LATER BROUGHT BACK INTO THE CLINIC. THE DEVICE WAS INTERROGATED WITHOUT ISSUE, AND PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE AND WOULD BE MONITORED REMOTELY.

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

  MAUDE report 11355717 ↗
• InjurySep 14, 2020Signal Artifact/Noise; Break; Over-Sensing; Low impedance; Signal Artifact/Noise; Break; Over-Sensing; Low impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-13527, 2017865-2020-13528. IT WAS REPORTED THE PATIENT PRESENTED REMOTELY. UPON REVIEW OF THE TRANSMISSION, IT WAS OBSERVED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR INAPPROPRIATELY DELIVERED ANTI-TACHYCARDIA PACING THERAPY AS A RESULT OF INCORRECT INTERPRETATION OF RHYTHM AND FAILED TO DELIVER SHOCK DUE TO THE LOW IMPEDANCE. THE PATIENT PRESENTED TO THE EMERGENCY ROOM WHERE IT WAS OBSERVED THE RIGHT VENTRICULAR LEAD AND ATRIAL LEAD HAD LEAD ABRASION LEADING TO OVER-SENSING NOISE, AS WELL AS LOW DEFIBRILLATION IMPEDANCE ON THE VENTRICULAR LEAD. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020 AND THE ATRIAL LEAD HAD BEEN SURGICALLY ADHERED TO ADDRESS THE ABRASION. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10528693 ↗
• DeathApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-02729. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-02731. 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. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 9974547 ↗
• MalfunctionJan 13, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY WITH VENTRICULAR LEAD NOISE. THE NOISE RESULTED IN OVERSENSING. NO PROGRAMMING CHANGES WERE MADE AND THE PATIENT WOULD CONTINUE TO BE MONITORED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9583146 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-05209, RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-05210, RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-05212. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR LEAD EXTRACTION PROCEDURE DUE TO POCKET EROSION. THE WHOLE SYSTEM WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion

  MAUDE report 8747080 ↗
• MalfunctionSep 19, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED A RISE IN PACING IMPEDANCE. THE LEAD UNDERWENT A DEFIBRILLATION THRESHOLD TEST ON (B)(6) 2018 AND REVEALED NORMAL HIGH-VOLTAGE IMPEDANCE. NO INTERVENTION WAS PERFORMED AND THE PATIENT WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890685 ↗
• InjurySep 5, 2018Over-Sensing; Retraction Problem; Device Dislodged or Dislocated; Over-Sensing; Retraction Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION. REVIEW OF THE TRANSMISSION NOTED OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE PATIENT PRESENTED FOR A CHEST X-RAY. THE LEAD HAD DISLODGED. THE PATIENT PRESENTED TO THE HOSPITAL FOR LEAD REVISION PROCEDURE ON (B)(6) 2018. UPON REPOSITIONING THE LEAD, THE HELIX WOULD NOT EXTEND. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. THE PATIENT HAD NO SYMPTOMS DURING OR AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847170 ↗
• InjuryAug 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD PULLED BACK SIGNIFICANTLY VIA REVIEW OF X-RAY. THE SVC COIL WAS BACK IN THE SUBCLAVIAN, AND IT WAS BELIEVED THE LEAD WAS CAUGHT UP IN THE TRICUSPID ANNULUS. THE LEAD WAS TESTED DAY OF PROCEDURE AND MEASUREMENTS WERE NORMAL. THE LEAD WAS SUCCESSFULLY REMOVED BY LASER RV LEAD EXTRACTION AND REPLACED WITH A NEW RV LEAD. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7804971 ↗
• DeathJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE PATIENT WAS IN HOSPICE AND REPORTEDLY PASSED PEACEFULLY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Death

  MAUDE report 7714555 ↗
• InjuryJul 2, 2018Retraction Problem; Decreased Sensitivity; High Capture Threshold; Retraction Problem; Decreased Sensitivity; High Capture Threshold

  NEW INFORMATION RECEIVED NOTES THAT THE PATIENT WAS STABLE DURING AND POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7655438 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.

• Z-0660-2016 · Nov 3, 2015 · Terminated
  Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
• Z-0458-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous
• Z-0457-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co