Protecta™ XT VR D314VRG (UDI 00613994677877)Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 00613994677877), received between Feb 9, 2017 and May 6, 2026 — classified as 4 deaths, 97 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (25 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 134 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS TAKEN OUT OF SERVICE. TWO MONTHS LATER A NEW ICD SYSTEM WAS IMPLANTED. THE LEAD STATUS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25096176 ↗
• MalfunctionFeb 17, 2026Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TONED DUE TO A CHARGE CIRCUIT TIMEOUT AFTER PREVIOUSLY BEING PROGRAMMED OFF. 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 24369030 ↗
• InjuryFeb 10, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). APPROXIMATELY THREE MONTHS LATER, THE ICD EXHIBITED EXCESSIVE CHARGE TIME AND IT WAS NOTED THE DEVICE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21345600 ↗
• MalfunctionJan 13, 2025Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED EXCESSIVE CHARGE TIME. THE DEVICE HAS SINCE REACHED END OF SERVICE (EOS) AND 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 21138365 ↗
• MalfunctionNov 26, 2024Failure to Charge; Failure to Charge

  IT WAS REPORTED, THAT THERE WAS A CHARGE CIRCUIT TIMEOUT ON A DEVICE. THAT WAS AT END OF SERVICE (EOS). THE PATIENT ELECTED TO NOT REPLACE THE DEVICE. AND IT 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 20781446 ↗
• InjuryAug 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR DEVICE HAD TO BE REPLACED DUE TO AN UNSPECIFIED MALFUNCTION. NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP WITH THE CLINIC. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986197 ↗
• MalfunctionJun 25, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO A SUSPECTED LOW VOLTAGE FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). SEVERAL ALERTS WERE TRIGGERED FOR LEAD NOISE AND HIGH/UNDEFINED PACING IMPEDANCE. THE PATIENT WAS HOSPITALIZED AND THE ICD FUNCTION WAS TURNED OFF AS IT WAS NOTED THE PATIENT IS CURRENTLY IN HOSPICE. THE SYSTEM REMAINS IN-SITU CURRENTLY AS THE PHYSICIAN IS DETERMINING NEXT STEPS DUE TO PATIENT'S PRE-EXISTING CONDITIONS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED A VARIATION IN PACING IMPEDANCE MEASUREMENTS, AND OVERSENSING. IN ADDITION, THE DEVICE REACHED END OF SERVICE (EOS), AND A CHARGE CIRCUIT TIMEOUT OCCURRED. THE CHARGE CIRCUIT WAS INACTIVE, AND THE PATIENT REFUSED TO HAVE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610026 ↗
• MalfunctionApr 22, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) . TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. THE MONITOR AND ICD REMAIN IN USE. NOPATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154503 ↗
• MalfunctionApr 15, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED, THAT THE PATIENT HAD A DECREASED HEART RATE. IT WAS FOUND, THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PACING BELOW THE PROGRAMMED LOWER RATE. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19111051 ↗
• MalfunctionFeb 7, 2024Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS AT END OF SERVICE (EOS) AND TRIGGERED A CHARGE CIRCUIT INACTIVE ALERT. IT WAS LATER REPORTED THAT A CHARGE CIRCUIT TIMEOUT OCCURRED. 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 18661543 ↗
• InjuryNov 16, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED.

  Patient problems: Bradycardia

  MAUDE report 18156421 ↗
• InjuryOct 31, 2023Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR CHARGE CIRCUIT INACTIVE. THE DEVICE HAD BEEN AT END OF SERVICE (EOS) FOR SEVERAL YEARS. 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 18039982 ↗
• MalfunctionSep 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO DO THE TELEMETRY AFTER THEY RECEIVED THE REMOTE MONITOR. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO CLINIC. THE REMOTE MONITOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2023, IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO SEND A MANUAL TRANSMISSION THROUGH THE REMOTE MONITOR TO THE REMOTE MONITOR NETWORK. 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 17834756 ↗
• InjurySep 21, 2023Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND SHORTNESS OF BREATH. THERE WAS EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) NOTED IN THE CAN TO SUPERIOR VENA CAVA (SVC) VECTOR. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Muscle Weakness/Atrophy

  MAUDE report 17787985 ↗
• DeathApr 18, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY A FAMILY MEMBER OF THE PATIENT THAT THE PATIENT HAD A HIGH HEART RATE AND A HEART ATTACK CAUSING THE PATIENT TO PASS OUT. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT. THE CALLER NOTED THAT THE ICD NEVER SHOCKED THE PATIENT THEY AND THAT ¿THERE WAS NO DETECTION ON TOP OF THE HEART.¿ THE PATIENT PASSED AWAY LESS THAN TWO WEEK LATER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Myocardial Infarction; Syncope/Fainting; Tachycardia

  MAUDE report 16765555 ↗
• MalfunctionMar 21, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT AN INTERROGATION SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS CURRENTLY AT END OF SERVICE (EOS), AND ALERTS HAD BEEN TRIGGERED FOR EXCESSIVE CHARGE TIME, CHARGE CIRCUIT TIMEOUT, AND CHARGE CIRCUIT INACTIVE. 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 16582555 ↗
• MalfunctionNov 30, 2022Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED THE PARAMETERS TO QUALIFY FOR RECOMMENDED REPLACEMENT TIME (RRT) HOWEVER THE RECOMMENDED REPLACEMENT TIME (RRT) HAD NOT YET TRIPPED. 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 15888913 ↗
• InjurySep 20, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INSULATION DAMAGE. THE LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER NOTED THAT ABOUT FIVE YEARS AGO THE PATIENT RECEIVED AND INAPPROPRIATE SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD HAS NOW BEEN EXPLANTED AND REPLACED, BUT NOT NECESSARILY EXPLANTED DUE TO THE INAPPROPRIATE THERAPY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 15455046 ↗
• InjurySep 15, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE PATIENT WAS REFERRED TO THE CLINIC. NO FURTHER INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP INVESTIGATION. 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 15426825 ↗
• InjuryAug 10, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) AND DELIVERED A SHOCK. IT WAS SUSPECTED THAT THE RHYTHM WAS ACTUALLY ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AND IS THEREFORE INAPPROPRIATE. 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 15202095 ↗
• MalfunctionJul 19, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TWO STORED EPISODES OF 60 HERTZ OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED OVER THREE YEARS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053477 ↗
• InjuryMay 20, 2022Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED AN ELECTRICAL RESET. IT WAS FURTHER REPORTED THAT THE ICD WAS AT END OF SERVICE (EOS) STATUS, THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP FOR APPROXIMATELY 7 YEARS. THE ICD WAS PROGRAMMED TO NOMINAL SETTINGS HOWEVER IT WAS REPORTED THAT THE PATIENT CODED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 14462350 ↗
• InjuryMay 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO A "POTENTIAL PERFORMANCE ISSUE". NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286593 ↗
• InjuryMar 30, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HOVERED AROUND RECOMMENDED REPLACEMENT TIME (RRT) VALUES FOR A PERIOD OF TIME, AND UPON TRIGGERING RRT WENT PREMATURELY TO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13949977 ↗
• InjuryFeb 16, 2022Adverse 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 INFECTION.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13542196 ↗