Evera™ S DR DDBC3D1 (UDI 00643169929159)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169929159), received between Apr 10, 2018 and May 20, 2025 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS AND NO CAPTURE. ADDITIONALLY, TRUE ATRIAL EVENTS WERE REPORTED AS IN THE REFRACTORY PERIOD, RESULTING IN A PACING ISSUE. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054070 ↗
• InjuryJun 3, 2024Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE INAPPROPRIATELY SHOCKED BY THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHEN THEY WERE NEAR AN "IMPROPERLY WIRED POOL PUMP MOTOR AND THERE WAS ELECTRICAL INTERFERENCE". THE ICD 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 19453859 ↗
• InjuryMay 7, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH STROKE SYMPTOMS AND A HEART RATE IN THE 40 BEATS PER MINUTE (BPM) RANGE. THE DEVICE WAS PROGRAMMED WITH LOWER RATE AT 60 BPM. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Stroke/CVA

  MAUDE report 19259987 ↗
• InjuryOct 30, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) APPEARED TO TAKE A LONGER AMOUNT OF TIME TO INITIATE THERAPY. THE ICD WAS REPROGRAMMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035896 ↗
• MalfunctionSep 20, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR TACHYCARDIA (VT) AND PROVIDED ANTI-TACHYCARDIA PACING. IT WAS SUSPECTED THAT THE RHYTHM WAS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE, MEANING THE PACING WAS INAPPROPRIATE. THE DEVICE REMAINS IN USE AND APPEARS TO BE CURRENTLY FUNCTIONING AS PROGRAMMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17781068 ↗
• InjuryMay 7, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED MULTIPLE INAPPROPRIATE THERAPIES AND MAY HAVE CONTRIBUTED TO A FALL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE ICD WAS "TURNED OFF" ACCORDING TO THE CALLER. THE ICD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Shock from Patient Lead(s)

  MAUDE report 14317803 ↗
• MalfunctionOct 29, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR PACING IMPEDANCE VARIATION AND SHORT V-V INTERVALS. THE NEXT DAY ANOTHER ALERT WAS TRIGGERED FOR HIGH PACING IMPEDANCE. OVERSENSING/NOISE WAS INDICATED IN STORED EPISODES. THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE FRACTURED AND REPROGRAMMING WAS PERFORMED TO TURN OFF DETECTIONS AND THE PATIENT WAS FITTED WITH A LIFEVEST. HIGH ATRIAL THRESHOLD AND OVERSENSING WAS NOTED. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE. THE LONGEVITY ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOTED TO HAVE DROPPED SIGNIFICANTLY OVER A SHORT PERIOD OF TIME. THE ICD 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 12720368 ↗
• MalfunctionMay 20, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART RATE LOWER THAN THE PROGRAMMED LOWER LIMIT OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). ADDITIONALLY, UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD IS OBSERVED, POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF EVENTS. THE ICD AND RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 11855709 ↗
• InjuryMay 7, 2021Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT INTO THE EMERGENCY ROOM DUE TO CARDIAC ARREST. THE NEXT DAY, THE PATIENT WAS UNRESPONSIVE AND INTUBATED. INTERROGATION DETERMINED THAT THE PATIENT APPEARED TO BE IN VENTRICULAR TACHYCARDIA (VT) APPROXIMATELY EIGHT MINUTES, OF WHICH THERAPY WAS WITHHELD DUE TO THE ONSET DISCRIMINATOR. THE DEVICE WAS REPROGRAMMED TO TURN THE DISCRIMINATOR OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 11790387 ↗
• InjuryDec 17, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) AND DELIVERED A SHOCK. IT WAS SUSPECTED THAT THE SHOCK WAS DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE DEVICE REMAINS IN USE AND CURRENTLY APPEARS TO BE FUNCTIONING AS PROGRAMMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11029122 ↗
• InjuryJul 22, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY DEPARTMENT SUSPECTING THEY HAD RECEIVED A SHOCK. A REMOTE MONITORING TRANSMISSION SHOWED NO THERAPY HAD BEEN PROVIDED. HOWEVER, REVIEW OF STORED EPISODES INDICATED THE PATIENT HAD BEEN TREATED FOR VENTRICULAR FIBRILLATION BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THE SHOCK WAS SUSPECTED TO BE INAPPROPRIATE. 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 10307269 ↗
• MalfunctionNov 26, 2019Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DETECTED A VENTRICULAR TACHYCARDIA NON-SUSTAINED (VTNS) EPISODE AS A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE. FOLLOW UP WAS CONDUCTED AND NO FURTHER INFORMATION WAS ASCERTAINED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378790 ↗
• InjuryApr 10, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY FOR AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS FAST SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 8499522 ↗
• MalfunctionMar 7, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) EXHIBITED GRAY BAR ON INTERROGATION, INDICATING LOW TELEMETRY VOLTAGE. THE ICDS WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8401772 ↗
• InjuryAug 7, 2018Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED DEVELOPING AN INFECTION AND THAT THE DEVICE IS "STUCK TO THE SKIN AND DOES NOT MOVE." A REQUEST FOR ADDITIONAL INFORMATION WAS MADE BUT NOT RECEIVED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REMAINS IN USE AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing; Skin Erosion; Unspecified Infection

  MAUDE report 7759994 ↗
• MalfunctionApr 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE PATIENT THAT THEIR CELLPHONE WAS AFFECTING THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PATIENT REPORTED EXPERIENCING CHEST PAIN UNTIL THE PHONE WAS MOVED AWAY FROM THE DEVICE. FOLLOW-UP WITH THE PATIENT¿S PHYSICIAN FOR FURTHER INFORMATION WAS ATTEMPTED AND MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 7418385 ↗