Evera™ S VR DVBC3D1 (UDI 00643169530324)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169530324), received between Feb 9, 2017 and Nov 3, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Sensing Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 3, 2021Open, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1305-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO HAVE PREMATURE BATTERY DEPLETION. THE DEVICE 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 18066498 ↗
• InjuryMar 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO "OTHER REASONS". NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506518 ↗
• InjuryFeb 13, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD DETECTION OF VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) EPISODES THAT WERE CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES BY THE DEVICE DISCRIMINATOR. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 16363236 ↗
• InjuryOct 14, 2021Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem; Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem

  IT WAS FURTHER REPORTED THAT IT WAS CONFIRMED THAT THE SHOCK WAS DUE TO ELECTROMAGNETIC INTERFERENCE THAT OCCURRED DURING A HIP REPLACEMENT PROCEDURE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12632621 ↗
• InjurySep 13, 2021Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING SURGERY THERE WAS OVERSENSING NOISE ON THE VENTRICULAR CHANNEL LEADING TO INAPPROPRIATE DETECTION OF VENTRICULAR FIBRILLATION (VF) AND INAPPROPRIATE THERAPY. THE DEVICE 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 12459752 ↗
• InjuryJul 1, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY SHOCKED THE PATIENT FOR DETECTING AN ATRIAL DRIVEN ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR) AS A VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF) EPISODE. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS HIGH THRESHOLDS AND DIMINISHED R-WAVE SENSING. THE 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 8748836 ↗
• InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH A SMALL AMOUNT OF BLEEDING AT THE INSERTION SITE AND A SMALL WOUND DEHISCENCE WAS OBSERVED. IT WAS FURTHER REPORTED THAT THERE WERE NO SIGNS OF INFECTION. A LIQUID TISSUE ADHESIVE WAS APPLIED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL CLINICAL STUDY.

  Patient problems: Wound Dehiscence

  MAUDE report 6469101 ↗
• InjuryFeb 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THE DEVICE WAS IMPLANTED AND FOLLOWING, MIGRATED FROM THE LEFT CHEST TO THE PATIENT¿S ARMPIT. AS THIS WAS NOT PAINFUL TO THE PATIENT IT REMAINED IN USE UNTIL IT WAS REMOVED AND REPLACED SIX YEARS LATER. THE REPLACED DEVICE MIGRATED TO THE ARMPIT AND THIS WAS VERY PAINFUL FOR THE PATIENT AND A REVISION WAS PERFORMED APPROXIMATELY FIVE WEEKS LATER. IT WAS ALSO REPORTED THAT WHILE THE PATIENT DOES NOT HAVE AN OVERT INFECTION, IT IS POSSIBLE AN OCCULT INFECTION IS CAUSING THE PAIN. DUE TO THE PAIN AND POSSIBILITY OF INFECTION, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD WERE REMOVED. A SUB-MUSCULAR RE-IMPLANT IS PLANNED. IT WAS NOTED THE RECURRENT MIGRATION MAY BE DUE TO THE PATIENT¿S CONNECTIVE TISSUE DISORDER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6317989 ↗