Secura® DR D224DRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00613994446633), received between Dec 9, 2016 and Aug 12, 2025 — classified as 1 death, 134 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (34 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 25 most recent of 194 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22783492 ↗
• MalfunctionNov 18, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED, RAISING CONCERNS ABOUT THE POSSIBILITY OF THE DEVICE HAVING NO BATTERY LEFT. THE PATIENT WAS LOST TO FOLLOW-UP, AND THERE WAS A POSSIBILITY THAT THE PATIENT HAD THEIR DEVICE REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. THE INABILITY TO INTERROGATE THE DEVICE WAS ATTEMPTED IN-OFFICE USING MULTIPLE PROGRAMMERS, BUT IT WAS EXPLAINED THAT THE OLDER DEVICE MIGHT NOT HAVE ENOUGH BATTERY LEFT TO ALLOW INTERROGATION. 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 20706867 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED DUE TO A NEAR EROSION AT THE IMPLANT SITE. A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 17999362 ↗
• InjuryOct 23, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS APPREHENSIVE TO HAVE AN MAGNETIC RESONANCE IMAGING (MRI) AFTER BEING SHOCKED NINE TIMES IN THE PAST BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FOLLOW UP WAS CONDUCTED WITH THE PATIENT'S FOLLOWING PHYSICIAN AND IT WASNOTED THAT THE SHOCKS THE PATIENT RECEIVED IN THE PAST WERE FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE DEVICE REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17987655 ↗
• InjuryOct 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR PREVIOUS DEVICE JUST STOPPED WORKING AND WAS REPLACED TWO DAYS LATER. A FOLLOW-UP INVESTIGATION DID NOT PROVIDE ANY ADDITIONAL DETAILS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17935671 ↗
• MalfunctionSep 14, 2023Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED END OF SERVICE (EOS) AND HAD AN ELECTRICAL RESET. WIRELESS TELEMETRY IS NO LONGER AVAILABLE ON THIS DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744917 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17603851 ↗
• MalfunctionJul 11, 2023Electrical /Electronic Property Problem; Delayed Charge Time; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ELECTROPHYSIOLOGIST AFTER BEING LOST TO FOLLOW-UP AND THEIR DEVICE WELL PAST ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO HAVE AN ALERT TONE PLAYING UPON INTERROGATION, AND A WARNING DISPLAYED STATING, "CHARGE CIRCUIT INACTIVE".  THERE WAS ALSO AN ALERT FOR EXCESSIVE CHARGE TIME NOTED. THE DEVICE HAS SINCE REACHED END OF SERVICE (EOS) STATUS. THE ALERTS WERE PROGRAMMED OFF, AND 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 17297969 ↗
• InjuryApr 26, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE REACHED NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI) AND HAD NO TELEMETRY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815339 ↗
• MalfunctionMar 31, 2023Battery Problem; Communication or Transmission Problem; Reset Problem; Battery Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN ELECTRICAL RESET OCCUR. IT WAS ALSO NOTED THAT AN ALERT WAS TRIGGERED FOR THE ICD REACHING END OF SERVICE (EOS) AND THAT WIRELESS TELEMETRY WAS NO LONGER AVAILABLE. THE ICD REMAINS IN-SITU. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656894 ↗
• InjuryMar 29, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR AN INACTIVE CHARGE CIRCUIT AFTER THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT). ADDITIONALLY, THE ICD HAD A CHARGE CIRCUIT TIMEOUT AND A LONGER THAN EXPECTED CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639624 ↗
• InjuryMar 24, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR CHARGE TIME THAT WAS LONGER THAN EXPECTED. THE DEVICE HAD A CHARGE CIRCUIT TIMEOUT ALERT AND A CHARGE CIRCUIT INACTIVE ALERT. THE DEVICE WAS AT END OF SERVICE (EOS). 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16612670 ↗
• MalfunctionJan 11, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED, AND NO DEVICE TONES WERE EMITTED WHEN PLACING A PROGRAMMER HEAD OVER IT. WITH THE WAND PLACED OVER THE DEVICE, A GREEN LIGHT HAD FLASHED MOMENTARILY, THEN WENT AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 16139606 ↗
• MalfunctionNov 10, 2022Failure to Charge; Charging Problem; Failure to Charge; Charging Problem

  IT WAS REPORTED THAT THE DEVICE REACHED END OF SERVICE (EOS) AND ALERTED FOR CHARGE CIRCUIT TIMEOUT. THE PATIENT HAS ELECTED TO KEEP THE DEVICE IMPLANTED, WITH ALL ALERTS PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771802 ↗
• MalfunctionJul 19, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PASSED END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. 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 15051494 ↗
• MalfunctionJun 29, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) APPROXIMATELY ONE YEAR PRIOR, AND THAT THE PATIENT DECLINED DEVICE REPLACEMENT. 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 14853621 ↗
• MalfunctionMar 3, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE DEVICE TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) IN 2019 AND THE PATIENT ELECTED NOT TO REPLACE THE DEVICE. IN ADDITION, A CHARGE CIRCUIT TIMEOUT OCCURRED. THE DEVICE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660608 ↗
• MalfunctionFeb 22, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT ABLE TO BE INTERROGATED.  TROUBLESHOOTING WAS PERFORMED, HOWEVER TELEMETRY WAS UNABLE TO BE ESTABLISHED.  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 13578917 ↗
• InjuryJan 18, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A "HARD LUMP ABOVE THE [IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)]." IT WAS FOUND THAT THE LUMP WAS THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD BEING TWISTED DUE TO TWITTERS' SYNDROME. IT WAS ALSO NOTED THAT TWIDDLERS' SYNDROME CAUSED DEVICE MIGRATION. THE DEVICE AND LEADS WERE REPOSITIONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Twiddlers Syndrome

  MAUDE report 13285983 ↗
• InjurySep 10, 2021Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEIR PHYSICIAN TURNED OFF THEIR DEVICE BECAUSE IT WAS NOT WORKING. THE DEVICE REMAINS INACTIVE IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453201 ↗
• MalfunctionAug 24, 2021Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR A CHARGE CIRCUIT TIMEOUT/CHARGE CIRCUIT INACTIVE. THE DEVICE ALERTED FOR RECOMMENDED REPLACEMENT TIME (RRT) AND IS AT END OF SERVICE (EOS). 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 12359460 ↗
• MalfunctionJul 8, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. THE ALERT WAS PROGRAMMED OFF AND 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 12135868 ↗
• InjuryJun 8, 2021Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TONING FOR END OF SERVICE (EOS) DUE TO A CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE. THE DEVICE WAS REPROGRAMMED AND CURRENTLY 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 11958255 ↗
• MalfunctionMay 4, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PATIENT HAS AN ABANDONED, NOT IN USE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STILL IMPLANTED ABDOMINALLY WHICH STARTED ALERTING. IT WAS NOTED THAT THE DEVICE HAD TRIGGERED ALERTS FOR CHARGE CIRCUIT TIMEOUT. THE DEVICE HAD BEEN REPLACED OVER THREE YEARS PRIOR WITH A PECTORAL DEVICE IMPLANT. THE ABANDONED ICD CURRENTLY REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770364 ↗
• InjuryApr 30, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 11753487 ↗