Quadra Assura™ CD3265-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 05414734505666), received between Jun 22, 2018 and Jan 19, 2022 — classified as 3 deaths, 48 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (29 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES AND THE PATIENT WAS IN STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13291193 ↗
• InjurySep 16, 2021Premature Discharge of Battery; Premature Discharge of Battery

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS ASYMPTOMATIC AND IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482851 ↗
• MalfunctionJun 4, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS OBSERVED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939812 ↗
• MalfunctionFeb 17, 2021Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC WITH AN EPISODE OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING CAUSED BY POST-PACED T-WAVE OVERSENSING ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PROGRAMMING CHANGES WERE RECOMMENDED, BUT WERE NOT PERFORMED AT THIS TIME. THE PATIENT DID NOT RECEIVE INAPPROPRIATE THERAPY DURING THE OVERSENSING EPISODE. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336426 ↗
• MalfunctionDec 24, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY. UPON REVIEW OF THE TRANSMISSION, IT WAS OBSERVED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS POST PACED T-WAVE OVERSENSING. NO PROGRAMMING CHANGES WERE COMPLETED TO ADDRESS THIS ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11072431 ↗
• MalfunctionSep 30, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PRESYNCOPE AND PRESENTED REMOTELY VIA MERLIN.NET. UPON INVESTIGATION, PACING INHIBITION DUE TO OVERSENSING WAS NOTED. THE OVERSENSING APPEARED TO BE A RESULT OF MYOPOTENTIAL OVERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED. NO OTHER PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: Dizziness; No Known Impact Or Consequence To Patient

  MAUDE report 10606608 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI (ELECTIVE REPLACEMENT INDICATOR) ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393754 ↗
• MalfunctionAug 10, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN. NET. REVIEW OF THE TRANSMISSION REVEALED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING DUE TO POST PACED T WAVE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED EGM (ELECTROGRAMS). THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10388002 ↗
• MalfunctionAug 5, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITING POST-PACED T-WAVE OVER-SENSING RESULTING IN EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING. PROGRAMMING INTERVENTIONS WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10367831 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10365471 ↗
• MalfunctionJul 15, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSIONS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T-WAVE OVERSENSING. THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. NO DEVICE INTERVENTION WAS PERFORMED BUT PROGRAMMING CHANGES WERE DISCUSSED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10277098 ↗
• MalfunctionJun 9, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC DEFIBRILLATOR EXHIBITED INTERMITTENT POST-PACED T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE ANY THERAPY DUE TO THE OVERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE AFTER REPROGRAMMING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10136346 ↗
• InjuryJun 2, 2020Failure to Interrogate; Battery Problem; Failure to Interrogate; Battery Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON INTERROGATION, IT WAS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR COULD NOT BE INTERROGATED. UPON REVIEW OF THAT LAST REMOTE TRANSMISSION, IT WAS REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR RECEIVED A BATTERY PERFORMANCE ALERT (BPA) ON (B)(6) 2020. FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10112771 ↗
• MalfunctionMay 19, 2020Battery Problem; Battery Problem

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND AWAITING EXPLANT. THE PATIENT WAS STABLE. FURTHER INFORMATION WAS REQUESTED, BUT NOT YET AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10069585 ↗
• InjuryMay 8, 2020Failure to Interrogate; Battery Problem; Inappropriate or Unexpected Reset; Failure to Interrogate; Battery Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED REMOTELY. IT WAS SEEN THAT THE DEVICE RECEIVED A BATTERY PERFORMANCE ALERT. NO PROCEDURE HAS TAKEN PLACE OR BEEN SCHEDULED AT THIS TIME. THE PATIENT WAS REPORTED STABLE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10040405 ↗
• InjuryApr 10, 2020High Capture Threshold; High Capture Threshold

  NEW INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS STABLE THROUGHOUT THE REVISION PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9950136 ↗
• MalfunctionFeb 24, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THAT WAS OVER-SENSING POST PACED T-WAVES. NO RESOLUTION WAS REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748391 ↗
• InjuryJan 8, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DUE TO PROGRAMMING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 9565817 ↗
• MalfunctionDec 2, 2019Over-Sensing; Over-Sensing

  NEW INFORMATION RECEIVED ON JUNE 17, 2020 INDICATES THAT ADDITIONAL EPISODES OF POST-PACED T-WAVE OVER-SENSING WERE NOTED VIA REMOTE TRANSMISSIONS. PROGRAMMING CHANGES WERE SUGGESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9396846 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO POST-OPERATION ISSUES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9242040 ↗
• MalfunctionSep 16, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED AT A FOLLOW-UP IN CLINIC WITH THEIR DEVICE IN BACK-UP VVI MODE. THE DEVICE WAS RESTORED TO NORMAL FUNCTION SUCCESSFULLY. THE PATIENT WAS STABLE BEFORE AND AFTER DEVICE RESTORATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9070208 ↗
• MalfunctionSep 11, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT REPORTED IN CLINIC. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS POST-PACED T-WAVE OVERSENSING. THE PATIENT DID NOT RECEIVE THERAPY DURING THE OVERSENSING. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8998366 ↗
• MalfunctionSep 11, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACED T WAVE OVERSENSING. THE DEVICE WAS REPROGRAMMED BY THE PHYSICIAN AND THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8994871 ↗
• InjurySep 6, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  NEW INFORMATION NOTES THAT THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8970990 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW-UP. THE PATIENT REPORTED A PROGRESSIVE DECLINE IN FUNCTIONAL STATUS, WHICH THE PHYSICIAN BELIEVED TO BE THE PATIENT'S CONGESTIVE HEART FAILURE WORSENING. THE PHYSICIAN DECIDED TO PROPHYLACTICALLY REPLACE THE PATIENT'S ADVISORY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8923845 ↗