Secura® VR D204VRMRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994714718), received between Oct 6, 2017 and Aug 9, 2024 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2024Failure 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) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) TWO YEARS AGO. THE ICD WAS NOW AT END OF SERVICE (EOS) AND CHARGE CIRCUIT INACTIVE OCCURRED. ALERTS WERE TRIGGERED FOR CHARGE CIRCUIT TIMEOUT AND FOR A LONG CHARGE TIME GREATER THAN 30 SECONDS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD CAPTURE THRESHOLD WAS UNAVAILABLE, AND CAPTURE COULD NOT BE CONFIRMED. THE RV LEAD REMAINS IN USE, AND THE 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 19954136 ↗
• InjuryJul 5, 2024Adverse 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 C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19680269 ↗
• InjuryJan 12, 2024Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504394 ↗
• InjuryMay 23, 2022Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A POWER ON RESET (POR). THE DEVICE WAS INTERROGATED IN CLINIC WITH A PROGRAMMER, THIS IS CONSIDERED INTERVENTION AS INTERROGATION CLEARS THE POR, AND WILL RESTORE SETTINGS. 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 14470020 ↗
• InjuryMar 11, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS. REVIEW OF A REMOTE TRANSMISSION SHOWED THAT THE PATIENT WAS TREATED WITH ANTI-TACHYCARDIA PACING AND SHOCKS FOR EPISODES OF VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) THAT WERE SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE THERAPIES WERE SUSPECTED TO BE INAPPROPRIATE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 13733636 ↗
• InjuryOct 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12665264 ↗
• InjuryFeb 29, 2020Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC, WHEREUPON TELEMETRY COULD NOT BE ACHIEVED WITH THE DEVICE, DESPITE THE USE OF MULTIPLE PROGRAMMERS. THERE WAS NO TONE UPON MAGNET APPLICATION, WITH THE DEVICE PALPABLE AND ITS LOCATION EVIDENT. THE PATIENT'S PREVIOUS DEVICE CHECK WAS APPROXIMATELY 10 MONTHS EARLIER, WITH BATTERY VOLTAGE OF 2.98 V AT THAT TIME. ADDITIONAL ATTEMPTS TO INITIATE TELEMETRY WERE UNSUCCESSFUL, AND ANOTHER ATTEMPT TO HEAR MAGNET TONES WITH A STETHOSCOPE WAS ALSO UNSUCCESSFUL. 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 9772596 ↗
• InjuryNov 2, 2019Premature Discharge of Battery; Delayed Charge Time; Device Sensing Problem; Premature Discharge of Battery; Delayed Charge Time; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY DELIVERED THERAPY SHOCKS FOR AN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS A VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF) EPISODE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LATER ALERTED FOR END OF SERVICE (EOS) AFTER A CHARGE CIRCUIT TIMEOUT HAD OCCURRED. THE DEVICE HAD A PREMATURE BATTERY DEPLETION. THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9270478 ↗
• InjuryOct 29, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) DURING AND POST ANTI-TACHYCARDIA PACING. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE SHOCKS FOR WHAT WAS SUSPECTED TO BE A SUPRAVENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISCRIMINATION ALGORITHM DID NOT WITHHOLD THERAPY. THE RV LEAD AND ICD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9251759 ↗
• InjuryAug 23, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS VT/VF (VENTRICULAR TACHYCARDIA/ VENTRICULAR FIBRILLATION). 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 8925541 ↗
• InjuryJul 27, 2018Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 7726497 ↗
• InjuryOct 6, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY WHICH WAS FELT TO BE DUE TO ATRIAL FIBRILLATION (AF) WITH A POORLY CONTROLLED RATE. THE PATIENT WAS PLACED ON AN ANTIARRHYTHMIC AND THE DEVICE REMAINS IN USE. 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: Shock from Patient Lead(s)

  MAUDE report 6923550 ↗
• MalfunctionOct 6, 2017Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES WHERE NOISE AND OVERSENSING WERE NOTED. FOLLOW UP WITH THE PHYSICIAN'S OFFICE INDICATED THE NOISE WAS DUE TO CAUTERIZING ON THE PATIENT'S LEFT ARM. 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 6923105 ↗
• InjuryOct 6, 2017Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT HAD BEEN TRIPPED ON TWO OCCASIONS. IT WAS NOTED THAT BOTH TIMES IT WAS DUE SIC (SENSING INTEGRITY COUNTER) AND VTNS (VENTRICULAR TACHYCARDIA NON-SUSTAINED) ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE EPISODES SHOW CLEAR EVIDENCE OF NON-PHYSIOLOGIC NOISE. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE THERE WAS INTERMITTENT NOISE THAT CAUSED THE PATIENT TO HAVE DEVICE ALERTS AND THEN GO TO THE EMERGENCY DEPARTMENT SEVERAL TIMES. THE PHYSICIAN HAD THE PATIENT COME INTO THE CLINIC AND PERFORMED MYOPOTENTIAL EXERCISES AND THE NOISE WAS NOT REPRODUCIBLE SO THE PHYSICIAN IS NOT SURE IF IT IS A FRACTURE OR DEVICE MALFUNCTIONING. THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD AND THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6920277 ↗