Ellipse™ CD1311-36Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Ellipse defibrillator is an implanted device that treats abnormal heart rhythms with shocks or pacing. Reports mostly describe unwanted or mistimed shocks, sensing errors, long charging times, lead damage, and pocket infections that led to device removal. There are 25 reports naming its identifier, including 2 deaths and 14 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 2
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05414734506106), received between Jun 15, 2018 and Jul 15, 2022 — classified as 2 deaths, 14 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (6 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
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Inappropriate/Inadequate Shock/Stimulation6
- Over-Sensing5
- Failure to Charge3
- Inappropriate or Unexpected Reset3
- Defective Device2
- Signal Artifact/Noise2
- Under-Sensing2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient5
- Therapeutic Effects, Unexpected4
- Unspecified Infection3
- Death2
- Chest Pain1
- Dyspnea1
- Erosion1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2022High impedance; Naturally Worn; High impedance; Naturally Worn
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING AND DEFIBRILLATION IMPEDANCE. FLUOROSCOPY IMAGING SHOWED THAT THE LEAD HAD EXTERNALIZED CONDUCTORS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15027427 ↗InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO A POCKET INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14690993 ↗InjuryMay 25, 2022Failure to Charge; Failure to Charge
IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED CAPACITOR CHARGE TIMEOUT. THE DEVICE WAS EXPLANTED AND REPLACED ON MAY 9, 2022. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14497890 ↗InjuryMar 30, 2022Delayed Charge Time; Delayed Charge Time
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY FOR A FOLLOW-UP ON (B)(6) 2022. REVIEW OF THE TRANSMISSION REVEALED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN ALERT FOR LONG CHARGE TIME. THE PROGRAMMING CHANGES WERE RECOMMENDED BUT WERE NOT PERFORMED AT THIS TIME. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13952843 ↗InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURING REFERENCE NUMBER: 2017865-2021-366350. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT'S IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. PATIENT CONSEQUENCES WERE NOT REPORTED.
Patient problems: Unspecified Infection
MAUDE report 12814165 ↗InjuryNov 15, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Defective Device; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Defective Device
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE SHOCK FROM THE RIGHT VENTRICULAR LEAD AFTER EPISODES OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE WERE OBSERVED. THE PHYSICIAN SUSPECTED THAT THIS WAS CAUSED BY A RIGHT VENTRICULAR LEAD FAILURE. ON (B)(6) 2021, THE LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. THERE WERE NO OTHER ADVERSE PATIENT CONSEQUENCES NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12813969 ↗MalfunctionOct 12, 2021Defective Device; Defective Device
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 12615297 ↗MalfunctionAug 30, 2021Over-Sensing; Device Sensing Problem; Over-Sensing; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, POST-SENSED T-WAVE OVER-SENSING AND SMALL R-WAVE AMPLIFICATION WAS FOUND ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO INTERVENTION WAS PERFORMED. PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12384661 ↗MalfunctionApr 27, 2021Failure to Charge; Failure to Charge
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. INTERROGATION SHOWED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAPACITOR FAILED TO CHARGE. THE PATIENT WAS ASYMPTOMATIC. NO CHANGES WERE MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11735161 ↗MalfunctionNov 25, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR WAS IN BACKUP VVI MODE. THE CAUSE OF THE BACKUP VVI WAS THOUGHT TO BE DUE TO LOW VOLTAGE. THE PATIENT WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10901160 ↗InjuryJul 30, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
NEW INFORMATION RECEIVED FROM THE FOLLOWING PACEMAKER CLINIC STATED THAT THE PATIENT WAS DOING FINE IN THE PREVIOUS FOLLOW UP IN CLINIC.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 10345179 ↗MalfunctionMay 29, 2020Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. IT WAS REVEALED THAT THE DEVICE EXHIBITED INTERMITTENT VENTRICULAR UNDER-SENSING. NO INTERVENTIONS OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10103130 ↗DeathJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-00138. 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.
Patient problems: Death
MAUDE report 9552813 ↗MalfunctionNov 21, 2019Failure to Charge; Failure to Charge
IT WAS REPORTED THAT AN ALERT WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR INDICATING A CAPACITOR CHARGE TIME LIMIT WAS REACHED. THE PATIENT WAS TO CONTINUE WITH FOLLOW UP IN CLINIC. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9356447 ↗MalfunctionSep 5, 2019Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A ROUTINE FOLLOW-UP. BATTERY LONGEVITY WAS PROJECTING 2.2 YEARS ON AUGUST 21, 2019 AFTER PROJECTING 4.4 YEARS IN NOVEMBER 2018 AND 5.5 YEARS IN APRIL 2018. THE CLINICIAN WAS CONCERNED ABOUT THE RAPID DECLINE IN BATTERY PROJECTIONS. THE PATIENT WAS STABLE, AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8967392 ↗InjuryAug 5, 2019Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO OVERSENSING AND NOISE NOTED ON DEVICE DURING CLINIC FOLLOW-UP. THE PATIENT HAD COMPETITOR LEAD WHICH EXHIBITED NOISE AND OVERSENSING. THE LEAD WAS CAPPED AND REPLACED ALONG WITH GENERATOR REPLACEMENT. THE PATIENT WAS STABLE BEFORE AND AFTER THE PROCEDURE.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8862414 ↗InjuryJul 14, 2019Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DELIVERED INAPPROPRIATE DEFIBRILLATION THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA. PROGRAMMING CHANGES WERE DISCUSSED.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8787555 ↗InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NEW INFORMATION RECEIVED ON (B)(4) 2019 INDICATED THAT THE PATIENT ALSO EXPERIENCED EROSION.
Patient problems: Erosion; Unspecified Infection
MAUDE report 8368083 ↗DeathFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 WAS SYSTOLIC HEART FAILURE.
Patient problems: Death
MAUDE report 8317967 ↗MalfunctionJan 30, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH CHEST PAIN, PALPITATIONS, AND SHORTNESS OF BREATH. INTERROGATION REVEALED THAT THE DEVICE ENTERED BACKUP VVI. A FIRMWARE DOWNLOAD WAS SUCCESSFULLY PERFORMED. THE PATIENT WAS STABLE.
Patient problems: Chest Pain; Dyspnea; Palpitations
MAUDE report 8290692 ↗InjuryNov 29, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION. UPON INTERROGATION, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD GIVEN INAPPROPRIATE SHOCK. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8117509 ↗InjuryJul 24, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS INAPPROPRIATELY DELIVERING THERAPY. CHEST X-RAYS WERE TAKEN AND NO ABNORMALITIES WERE SHOWN IN THE SYSTEM. THE RIGHT VENTRICULAR LEAD ALSO SHOWED NORMAL MEASUREMENTS. NO PROGRAMMING CHANGES WERE MADE AT THE TIME.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 7713860 ↗InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS EXPLANTED BECAUSE THE PATIENT DEVELOPED SEPSIS. THE PATIENT WAS STABLE THROUGHOUT THE WHOLE PROCEDURE.
Patient problems: Sepsis
MAUDE report 7690459 ↗MalfunctionJul 11, 2018Communication or Transmission Problem; Inappropriate or Unexpected Reset; Communication or Transmission Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY THROUGH MERLIN.NET. UPON INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED BACKUP VVI OPERATION. THE PATIENT WAS BROUGHT IN CLINIC AND A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY. THE PATIENT WOULD CONTINUE TO BE FOLLOWED-UP NORMALLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7679802 ↗InjuryJun 15, 2018Over-Sensing; Defibrillation/Stimulation Problem; Under-Sensing; Over-Sensing; Defibrillation/Stimulation Problem; Under-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER EXPERIENCING SYNCOPE DUE TO VENTRICULAR FIBRILLATION (VT). IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED UNDERSENSING DURING VT AND THERAPY WAS NOT PROVIDED. OVERSENSING EPISODES WERE ALSO NOTED ON THE DEVICE. THE PATIENT WAS TREATED WITH MEDICATION AND NO PROGRAMMING CHANGES WERE MADE.
Patient problems: Syncope
MAUDE report 7605686 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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