OPTISURE™ LDP220Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05414734507455), received between Oct 16, 2018 and Sep 17, 2026 — classified as 1 death, 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Intermittent Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812444 ↗
• InjuryJul 22, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO CLINIC WITH HEART FAILURE AND ACTIVELY EXPERIENCING ATRIAL FIBRILLATION. THE RIGHT VENTRICULAR LEAD HAD ELEVATED PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD. NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure

  MAUDE report 22571724 ↗
• InjuryApr 18, 2023Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, IT WAS FOUND THAT THE PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED NOISE AND LOW PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762430 ↗
• InjuryNov 19, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED INAPPROPRIATE SHOCKS DUE TO OVERSENSING NOISE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830356 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION NOTES THAT A SMALL AREA AT THE END OF THE POCKET INCISION SITE HAS NOT HEALED POST IMPLANT. THE DEFIBRILLATOR AND LEAD WERE EXTRACTED. POSSIBLE RE-IMPLANT CONTRALATERALLY TO ALLOW THE SKIN TO FULLY HEAL. IT WAS UNSURE IF THE PATIENT SUFFERED AN INFECTION BUT WAS GIVEN ANTIBIOTICS PREEMPTIVELY. THE PATIENT WAS STABLE.

  Patient problems: Hematoma; Wound Dehiscence

  MAUDE report 10928919 ↗
• InjuryNov 16, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THE RIGHT VENTRICULAR LEAD HAD PERFORATED AND WAS LYING NEAR THE DIAPHRAGM. THE PATIENT PRESENTED IN CLINIC WITH SEVERE STIMULATION AND THE LEAD WAS ALSO OVERSENSING. THE VENTRICULAR LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Cardiac Perforation; Discomfort

  MAUDE report 10848153 ↗
• InjurySep 2, 2020High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR SYSTEM IMPLANT ON (B)(6) 2020. UPON DEVICE INTERROGATION PRIOR TO DISCHARGE, THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE INCREASED. AT IMPLANT, THE IMPEDANCE WAS WITHIN NORMAL LIMITS. THE RV LEAD IMPEDANCE FURTHER INCREASED WHEN THE PATIENT LAID DOWN. THE RV THRESHOLD WAS NOTED TO ALSO RISEN. THE HIGH VOLTAGE LEAD IMPEDANCE WAS NORMAL. THE PATIENT REPORTEDLY EXPERIENCED A HEADACHE AND POCKET TENDERNESS. X-RAY TESTING WAS REVIEWED AND THE ANTEROPOSTERIOR (AP) VIEW APPEARED TO BE UNCHANGED FROM THE POST-IMPLANT X-RAY. THE LATERAL VIEW FROM THE PRE-DISCHARGE X-RAY SHOWED THE LEAD TO BE POINTING ANTERIOR IN THE RV. THE PHYSICIAN SUSPECTED MICRO-PERFORATION. A 2D ECHO WAS ORDERED, AND NOTHING DEFINITIVE WAS FOUND. THE PHYSICIAN WAS UNSURE WHETHER MICRO-PERFORATION OCCURRED. PROGRAMMING CHANGES WERE ALSO MADE TO ALLEVIATE THE RISK OF THE PATIENT RECEIVING A VIBRATORY ALERT FOR LEAD IMPEDANCE PRIOR TO A SCHEDULED LEAD REVISION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN FELT A LITTLE RESISTANCE WHEN PULLING THE LEAD, LEAD, BUT HE DIDN'T KNOW IF THAT WAS BECAUSE IT WAS THROUGH THE TISSUE, OR JUST EMBEDDED

  Patient problems: Cardiac Perforation; Discomfort; Dizziness

  MAUDE report 10483055 ↗
• InjuryMar 24, 2020Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A POST-OPERATIVE CHECK. DEVICE INTERROGATION NOTED INTERMITTENT CAPTURE ON THE RIGHT VENTRICULAR LEAD AT HIGH OUTPUTS. THE LEAD WAS REPOSITIONED SUCCESSFULLY ON (B)(6) 2020. THE PATIENT WAS STABLE THROUGHOUT THE REVISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9870891 ↗
• InjuryJan 20, 2020Intermittent Capture; High Capture Threshold; Intermittent Capture; High Capture Threshold

  WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR AN UNRELATED REASON. A DEVICE CHECK REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED INCREASED CAPTURE THRESHOLDS. THE PATIENT WAS REFERRED FOR SUBSEQUENT LEAD REVISION. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9608260 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-16886; 2938836-2019-16888. IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH POST-IMPLANT WOUND CARE AND THE WOUND NEVER HEALED COMPLETELY. IT EVENTUALLY STARTED DRAINING AND THE PHYSICIAN REMOVED THE WHOLE SYSTEM WITHOUT ISSUE. THE PHYSICIAN DID NOT BELIEVE THE DEVICE OR LEADS WERE RELATED TO THE INFECTION. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9406791 ↗
• MalfunctionOct 10, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A PULSE GENERATOR IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO IMPLANT THE PASSIVE FIXATION RIGHT VENTRICULAR LEAD. THE LEAD EXHIBITED RANDOM OVERSENSING ONCE THE LEAD WAS CONNECTED TO THE PULSE GENERATOR. THE OVERSENSING APPEARED TO INTERMITTENTLY SENSED SIGNALS FROM THE ATRIAL CHANNEL AND HAD BASELINE NOISE OVERSENSING. THE LEAD WAS RE-ATTACHED TO THE PULSE GENERATOR BUT THE OVERSENSING PERSISTED. THE PHYSICIAN RE-POSITIONED THE LEAD BUT WAS UNABLE TO ACHIEVE SATISFACTORY RESULTS. THE LEAD WAS THEN REPLACED WITH AN ACTIVE FIXATION LEAD WHICH EVENTUALLY RESOLVED THE NOISE ISSUE. THE IMPLANT WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9177303 ↗
• InjuryMay 20, 2019Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR WOUND CHECK. VERY HIGH AND VARIABLE CAPTURE THRESHOLD WAS NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. THE CAPTURE THRESHOLD WAS HIGHER THAN THE PROGRAMMED OUTPUT, BUT THE PATIENT DID NOT NEED TO PACE. X-RAYS SHOWED THAT THE LEAD HAD ADVANCED AND WRAPPED AROUND THE RIGHT VENTRICULAR APEX. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8626332 ↗
• InjuryMay 6, 2019High impedance; High Capture Threshold; High impedance; High Capture Threshold

  NEW INFORMATION NOTES THAT WHILE MONITORING THIS LEAD, THE VALUES FOR PACING IMPEDANCE, DEFIBRILLATION IMPEDANCE, AND CAPTURE THRESHOLD HAD CONSTANTLY RISEN. LEAD EXTRACTION HAD BEEN DISCUSSED BUT NOT SCHEDULED AS OF YET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584537 ↗
• InjuryJan 22, 2019Low impedance; Decreased Sensitivity; Device Dislodged or Dislocated; High Capture Threshold; Low impedance; Decreased Sensitivity; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP. THE RIGHT VENTRICULAR LEAD EXHIBITED INCREASED CAPTURE THRESHOLD DECREASED R-WAVE SENSING AMPLITUDES, AND DECREASED LEAD IMPEDANCE. LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE WITH NO COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8267527 ↗
• DeathOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE WAS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTED THE DEATH WAS RELATED TO THE DEVICE. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 7972235 ↗

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-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
• 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