QUADRA ASSURA MP™ CD3269-40QRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05414734505710), received between Jun 12, 2018 and Oct 25, 2021 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2021Over-Sensing; Over-Sensing

  RELATED MANUFACTURER'S REFERENCE NUMBER: 2017865-2021-34160. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A GENERATOR CHANGE PROCEDURE DUE TO WIDE QRS ON (B)(6) 2021. DURING EXAMINATION, IT WAS NOTED THAT THERE WAS NOISE ON THE RIGHT ATRIAL (RA) LEAD WHICH LED TO EPISODES OF INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). THE PHYSICIAN CAPPED AND REPLACED THE RA LEAD ON (B)(6) 2021. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692732 ↗
• MalfunctionJan 5, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE OUT PROCEDURE DUE TO NORMAL BATTERY DEPLETION. UPON INTERROGATION, FIVE POST-PACED T-WAVE OVER-SENSING EPISODES WERE NOTED ON THE DEVICE. PROGRAMMING CHANGES WERE DISCUSSED; THE PHYSICIAN ELECTED TO LEAVE ALL SETTINGS AS IS AND MONITOR THE PATIENT. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 11117823 ↗
• MalfunctionDec 27, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP. UPON REVIEW, IT WAS DISCOVERED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED POST-PACE T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527764 ↗
• MalfunctionAug 6, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC, POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON VENTRICULAR CHANNEL ON A STORED ELECTROGRAM (EGM). PROGRAMMING CHANGES WERE MADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8867426 ↗
• MalfunctionJul 23, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR DELIVERED INAPPROPRIATE ANTITACHYCARDIA PACING ON (B)(6) 2019. THE DEVICE WAS REPROGRAMMED ON (B)(6) 2019. THE PATIENT WAS ASYMPTOMATIC DURING THE INAPPROPRIATE ANTITACHYCARDIA PACING EPISODE, WAS ASYMPTOMATIC AFTER REPROGRAMMING, AND WOULD BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8819725 ↗
• MalfunctionJun 10, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP, DEVICE INTERROGATION REVEALED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING, WHICH WAS CAUSED BY POST PACED T WAVE OVERSENSING. PROGRAMMING CHANGE WAS MADE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8685124 ↗
• MalfunctionMay 6, 2019Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED NON-FUNCTIONING RF TELEMETRY. NO INTERVENTION WAS REPORTED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8583453 ↗
• InjuryMay 1, 2019Battery Problem; Battery Problem

  FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8570295 ↗
• InjuryApr 19, 2019Battery Problem; Battery Problem

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8533481 ↗
• MalfunctionMar 5, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED PATIENT¿S DEVICE EXHIBITED POST-PACED T-WAVE OVERSENSING THAT CAUSED FIFTY-TWO PERCENT BIVENTRICULAR PACING NOTED DURING A FOLLOW-UP CLINIC CHECK. PROGRAMMING CHANGES WERE MADE. PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8393015 ↗
• InjuryDec 21, 2018Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR COULD NOT BE INTERROGATED. IT WAS SUSPECTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE PATIENT PRESENTED ON (B)(6) 2018 FOR REPLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE DEVICE WAS SWOLLEN AND HAD A ¿SPLIT¿. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8191391 ↗
• MalfunctionDec 5, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT INTERMITTENT UNDERSENSING WAS OBSERVED ON THE DEVICE DURING VENTRICULAR TACHYCARDIA EPISODES THAT WAS CONVERTED. PROGRAMMING CHANGES WERE MADE TO ADDRESS THE ISSUE. PATIENT WAS STABLE.

  Patient problems: Ventricular Tachycardia

  MAUDE report 8136155 ↗
• MalfunctionNov 27, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES WERE OBSERVED VIA FOLLOW-UP REMOTE. REVIEW OF THE EGM NOTED POST-SENSED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE. PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109310 ↗
• MalfunctionNov 14, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW-UP. UPON REVIEW OF THE STORED ELECTROGRAM, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES DUE TO POST-PACED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8069368 ↗
• MalfunctionJul 8, 2018Over-Sensing; Failure to Sense; Over-Sensing; Failure to Sense

  IT WAS REPORTED THAT WHEN PATIENT PRESENTED REMOTELY VIA MERLIN.NET TRANSMISSION, FAR FIELD R-WAVE OVERSENSING ISSUE WAS OBSERVED. ALSO, THERE WAS NO SENSING IN THE ATRIUM. PROGRAMMING CHANGES WERE RECOMMENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7668773 ↗
• InjuryJun 12, 2018Adverse 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 Known Impact Or Consequence To Patient

  MAUDE report 7594779 ↗