Epsila EV™ MRI SureScan™ EV240152Recalls & reported problems
Medtronic, Inc. · LEAD EV240152 SUBSTERNAL LEAD 52CM · Class 3 · Implant
All models of Epsila EV MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Epsila EV MRI SureScan lead has 85 reports in the FDA database, including 2 deaths and 44 injuries. Many reports describe oversensing and signal noise on the lead, and some describe inappropriate shocks. Reports rose to 54 in the past 12 months from 25 the year before. 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
- 91
- Deaths reported
- 2
- Injuries reported
- 43
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00763000369767), received between May 16, 2024 and Sep 30, 2026 — classified as 2 deaths, 43 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (60 reports).
1 other recall cover devices cleared under the same FDA submission (P220012); 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.
Reports received per month
Most reported problems
Device problems
- Over-Sensing60
- Signal Artifact/Noise42
- Under-Sensing21
- Decreased Sensitivity12
- Inappropriate/Inadequate Shock/Stimulation12
- Low impedance8
- High impedance6
- Impedance Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions70
- Shock from Patient Lead(s)13
- Chest Pain4
- Discomfort2
- Perforation2
- Swelling/ Edema2
- Anxiety1
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Signal Artifact/Noise; Over-Sensing
It was reported that noise episodes that were likely due to myopotentials were observed on the Extravascular (EV) lead. The EV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945915 ↗MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936259 ↗MalfunctionSep 24, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing
It was reported that there was a noise warning for oversensing noise episodes on the Extravascular (EV) lead. Also present were episodes of T-Wave Oversensing (TWOS) and undersensing was also noted. The EV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883595 ↗MalfunctionSep 16, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793453 ↗MalfunctionSep 15, 2026Signal Artifact/Noise; Over-Sensing
It was reported that the patient had an unknown device tone and reported "symptoms". There was a stored episode for oversensing on the Extravascular (EV) lead resulting in misclassification of episode type. Additionally, episodes of oversensing noise were observed. The EV lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Insufficient Information
MAUDE report 50777893 ↗MalfunctionSep 15, 2026Over-Sensing; Under-Sensing
It was reported that there was a stored episode for oversensing and on the Extravascular (EV) lead resulting in misclassification of episode type. In addition, there were stored episodes for undersensing on the EV lead. The EV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776353 ↗MalfunctionSep 11, 2026Signal Artifact/Noise; Over-Sensing; Decreased Sensitivity
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737229 ↗MalfunctionSep 8, 2026Signal Artifact/Noise; Over-Sensing
It was reported that non-sustained events, p-wave oversensing and noise oversensing were observed on the Extravascular (EV) lead. The EV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672302 ↗MalfunctionAug 28, 2026Signal Artifact/Noise; Over-Sensing
It was reported that there was a lead warning for oversensing noise on the Extravascular (EV) lead. The EV lead remains in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502245 ↗MalfunctionAug 14, 2026Signal Artifact/Noise; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256147 ↗MalfunctionAug 11, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209571 ↗MalfunctionJul 30, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086856 ↗InjuryJul 10, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK DURING A SEVERE STORM WHILE THEIR PHONE WAS IN THEIR HAND. THE PATIENT FOUND THIS "UNACCEPTABLE AND PAINFUL". THE EXTRAVASCULAR (EV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain; Shock from Patient Lead(s)
MAUDE report 25779522 ↗InjuryJul 7, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED FIVE INAPPROPRIATE DEFIBRILLATION SHOCKS WHILE ON A RUN DUE TO APPARENT EXTRAVASCULAR (EV) LEAD P-WAVE OVERSENSING (PWOS), T-WAVE OVERSENSING (TWOS), AND R-WAVE DOUBLE-COUNTING. SIMILAR EPISODES WERE DETECTED AS OVERSENSING NOISE. THE SENSING VECTOR WAS REPROGRAMMED, AND THE EV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25733574 ↗MalfunctionJun 23, 2026Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT THE EXTRAVASCULAR (EV) LEAD TRIGGERED A WARNING FOR NOISE DUE TO ONE OR MORE EPISODES OF OVERSENSING NOISE. THE EV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25594818 ↗MalfunctionJun 17, 2026Signal Artifact/Noise
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE EXTRAVASCULAR (EV) LEAD WAS CONNECTED TO THE ANALYZER CABLES, R-WAVES WE RE APPROPRIATELY MEASURED. AFTER THE PHYSICIAN PULLED THE LEAD BACK SLIGHTLY AND AFTER RECONNECTING THERE WAS NOTHING BUT NOISE ON THE ANALYZER. THE CABLES WERE RECONNECTED AND THE SAME RESULT OCCURRED. A SECOND PAIR OF ANALYZER CABLES WAS TRIED WITH THE SAME RESULT. THE PHYSICIAN TOOK A SECOND LEAD AND IMPLANTED IT WITH NO ISSUES NOTED. THE INITIAL EV LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536682 ↗MalfunctionJun 17, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE DAY AFTER IMPLANT, IT WAS NOTED THAT THE EXTRAVASCULAR (EV) LEAD HAD A SHIFT TO THE PATIENT'S LEFT. LEAD SENSING WAS UNCHANGED. DEFIBRILLATION THRESHOLD TESTING WAS SUCCESSFUL. THE EV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535782 ↗MalfunctionJun 16, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing
IT WAS REPORTED THAT OVERSENSING OF NOISE WAS OBSERVED ON THE EXTRAVASCULAR (EV) LEAD. R-WAVE UNDERSENSING AND T-WAVE OVERSENSING (T WOS) WAS ALSO NOTED. THE EV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25524060 ↗MalfunctionJun 16, 2026Over-Sensing
IT WAS REPORTED THAT THE STORED EPISODES FOR OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE WERE OBSERVED ON THE EXTRAVASCULAR (EV) LEAD. THE EV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523150 ↗InjuryJun 16, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. REPROGRAMMING WAS DONE AND THE EXTRAVASCULAR (EV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25522222 ↗MalfunctionJun 8, 2026Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. OVERSENSING ON THE EXTRAVASCULAR (EV) LEAD WAS OBSERVED RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. THERE WAS ALSO A NOISE WARNING FOR OVERSENSING NOISE AND T-WAVE OVERSENSING (TWOS) EPISODES. THE EV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Chest Pain
MAUDE report 25431035 ↗MalfunctionJun 8, 2026Signal Artifact/Noise
IT WAS REPORTED BY THE PATIENT THAT THEIR NEW DEVICE IS "THROWING SOME NOISE" AND IT HAD TO BE CHECKED. THE EXTRAVASCULAR (EV) LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429779 ↗InjuryMay 19, 2026Decreased Sensitivity; Device Dislodged or Dislocated; Impedance Problem
IT WAS REPORTED THAT DURING THE NEXT-DAY DEVICE CHECK POST-IMPLANT OF THE EXTRAVASCULAR (EV) LEAD, A DECLINE IN R-WAVE MEASUREMENTS COMPARED TO IMPLANT WAS NOTED AS WELL VARIATIONS IN SENSING DURING RESPIRATION CYCLES. PACING IMPEDANCES WERE ALSO NOTED TO BE SLIGHTLY LOWER COMPARED TO AT-IMPLANT VALUES. X-RAY IMAGING WAS PERFORMED WHICH SHOWED THE EV LEAD HAD MIGRATED. REPROGRAMMING WAS PERFORMED TO IMPROVE SENSING, PREEMPTIVELY INCREASE OVERSENSING PROTECTION TO MAXIMUM, AND TO OBTAIN A NEW WAVELET TEMPLATE. THE PHYSICIAN WAS NOT CONCERNED ABOUT THE MIGRATION GIVEN FINAL ELECTRICAL MEASUREMENTS POST-REPROGRAMMING, SO THE LEAD REMAINS IN USE IN THE MIGRATED POSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222183 ↗MalfunctionMay 19, 2026Over-Sensing
IT WAS REPORTED THAT EPISODES CLASSIFIED AS T-WAVE OVERSENSING (TWOS) WERE RECORDED. REVIEW OF THE STORED ELECTROGRAMS (EGM) SHOWED APPARENT P-WAVE OVERSENSING (PWOS) FROM THE EXTRAVASCULAR (EV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25218026 ↗InjuryMay 5, 2026Signal Artifact/Noise; Over-Sensing; Failure to Convert Rhythm
IT WAS REPORTED THAT THE PATIENT HAD RECURRENT VENTRICULAR TACHYCARDIA (VT) THAT COULD NOT BE TERMINATED WITH OVER TWENTY SHOCKS. ADDITIONALLY, OVERSENSING NOISE WAS OBSERVED ON THE EXTRAVASCULAR (EV) LEAD. BOTH THE EV LEAD AND THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) WERE EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Tachycardia
MAUDE report 25086717 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P220012. One submission often covers many models, so check the product and lot details in each record.
- Z-0726-2026 · Oct 29, 2025 · Open, ClassifiedAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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