Secura® DR D204DRMRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00613994714695), received between Apr 6, 2017 and Jan 25, 2024 — classified as 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2024Device Alarm System; Failure to Interrogate; Device Alarm System; Failure to Interrogate

  IT WAS REPORTED THAT WHEN TRYING TO INTERROGATE THE PATIENT¿S DEVICE WITH A MONITOR A "NO DEVICE FOUND" MESSAGE POPULATED. THE DEVICE WAS ATTEMPTED TO BE INTERROGATED MULTIPLE TIMES WITH THE MONITOR, BUT ONLY ONE ATTEMPT WAS OPERABLE. IT WAS ALSO NOTED THAT WHEN A MAGNET WAS PLACED OVER THE DEVICE NO TONES WERE EMITTED. THE PATIENT WAS IN PERSISTENT VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18582318 ↗
• MalfunctionDec 3, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EMITTING AUDIBLE TONES AND HAD A CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE DEVICE HAS REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE ICD REMAINS IN USE AS THE PATIENT DOES NOT PLAN ON GETTING THE DEVICE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924343 ↗
• MalfunctionOct 19, 2020Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) WENT INTO END OF SERVICE (EOS) WHEN EXCESSIVE CHARGE TIME OCCURRED. 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; No Consequences Or Impact To Patient

  MAUDE report 10698221 ↗
• MalfunctionMay 13, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT AN ALLIED HEALTH PROFESSIONAL INDICATED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY DID NOT LAST AS LONG AS IT SHOULD HAVE. UPON REVIEW, IT WAS NOTED THAT THE ICD BATTERY CURVE DID NOT APPEAR TO BE ABNORMAL. THE ICD 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 10051190 ↗
• InjuryFeb 24, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED POSSIBLE PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9746841 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED DUE TO AN INFECTION AND GROWTH ON THE LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9603754 ↗
• InjuryDec 26, 2019Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A CHARGE CIRCUIT TIMEOUT FOR PROLONGED CHARGE TIME AT END OF SERVICE (EOS). THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521382 ↗
• InjuryNov 15, 2019Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING RECORDED EPISODES OF ATRIAL FIBRILLATION (AF). ADDITIONALLY, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILED TO COMPLETELY DETECT AN ARRHYTHMIA, MARKING IT AS TERMINATED WHEN IT WAS NOT. THE ICD WAS REPROGRAMMED, AND THE DEVICE AND LEAD REMAIN 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 9328131 ↗
• InjuryOct 29, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. THE ICD WAS EX PLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9250259 ↗
• InjuryAug 21, 2019Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED AN ALERT FOR EXCESSIVE CHANGE TIME AND HAD TRIGGERED END OF SERVICE (EOS). THE DEVICE HAS BEEN EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8915424 ↗
• InjuryAug 15, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DUE TO AF (ATRIAL FIBRILLATION) WITH RVR (RAPID VENTRICULAR RESPONSE). 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 8898722 ↗
• InjuryApr 24, 2019Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ALERTED FOR A CHARGE CIRCUIT TIMEOUT AND LONG CHARGE TIME. THE DEVICE WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8544176 ↗
• InjuryApr 18, 2019Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED MULTIPLE ELECTRICAL RESETS. THE RESETS WERE CLEARED, AND THE DEVICE THERAPIES WERE PROGRAMMED OFF DUE TO THE PATIENT BEING IN HOSPICE. 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 8529560 ↗
• InjuryJan 17, 2019Electromagnetic Interference; Over-Sensing; Communication or Transmission Problem; Inappropriate or Unexpected Reset; Electromagnetic Interference; Over-Sensing; Communication or Transmission Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT WENT TO A JUNK YARD AND WAS NEAR A MAGNET. A POWER ON RESET WAS NOTED TO HAVE OCCURRED. THE RESET WAS CLEARED. APPROXIMATELY FOUR MONTH LATER, WIRELESS TELEMETRY WAS NOTED TO BE DISABLED. 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 8259064 ↗
• InjurySep 25, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN EARLY DROP IN BATTERY VOLTAGE. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7907469 ↗
• InjurySep 13, 2018Migration or Expulsion of Device; Battery Problem; Migration or Expulsion of Device; Battery Problem

  IT WAS REPORTED THAT THE DEVICE HAD MOVED LATERAL OVER TIME AND THE PHYSICIAN DECIDED TO PERFORM A POCKET REVISION. THE DEVICE WAS NEARING RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7875464 ↗
• MalfunctionAug 24, 2018Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INCORRECTLY RECORDING DATA. IT WAS NOTED THAT THE ISSUE APPEARED TO BE ASSOCIATED WITH A TECHNICAL NOTE. THE DEVICE IS STILL 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 7812964 ↗
• MalfunctionApr 10, 2018Pacing Problem; Invalid Sensing; Pacing Problem; Invalid Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING FOR SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT). FOLLOW-UP WAS ATTEMPTED WITH THE PHYSICIAN; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. 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 7414100 ↗
• InjuryFeb 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION WITH DEVICE LONGEVITY OF LESS THAN FIVE YEARS. IT WAS ALSO REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD HAD ELEVATED THRESHOLDS. THE ICD WAS EXPLANTED AND REPLACED. THE RV LEAD 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 7254236 ↗
• InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE EXPERIENCED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7091728 ↗
• InjuryOct 9, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT SUDDENLY DEVELOPED RAPID PALPITATIONS AND RECEIVED AN INAPPROPRIATE SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). INTERROGATION OF THE ICD INDICATED THAT IT WAS IRREGULAR AND RAPID. IT WAS NOTED THAT IT WAS LIKELY DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD WAS REPROGRAMMED AND THE ISSUE WAS NOTED TO BE RESOLVED. IT WAS FURTHER REPORTED THAT ICD WAS UPGRADED TO A BI-VENTRICULAR ICD. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Palpitations; Shock from Patient Lead(s)

  MAUDE report 6930684 ↗
• InjuryOct 6, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THE DEVICE HAD DETECTED AS VENTRICULAR TACHYCARDIA (VT). FOLLOW-UP WAS ATTEMPTED WITH THE PHYSICIAN; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. 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 6920365 ↗
• InjuryAug 9, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN ANTICIPATED. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781594 ↗
• MalfunctionApr 6, 2017Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPERIENCING FREQUENT INTERMITTENT ATRIAL UNDERSENSING. THE DEVICE WAS ALREADY PROGRAMMED AT ITS MOST SENSITIVE SETTING. THE DEVICE IS STILL 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 6465832 ↗