Protecta™ XT VR D314VRMRecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00613994714596), received between Feb 9, 2017 and May 6, 2023 — classified as 50 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) WITH SYNCOPE. THE DEVICE WAS NOTED TO BE OVERHEATING. THE DEVICE ALERTED FOR RECOMMENDED REPLACEMENT TIME (RRT) AND HAD LOW BATTERY VOLTAGE WITH AN END OF SERVICE (EOS) MESSAGE. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR HIGH PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 16882819 ↗
• InjuryJan 23, 2023Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED VIA FOLLOW-UP THAT THE DEVICE BATTERY WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225702 ↗
• InjuryDec 7, 2022Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS MONTHS PAST END OF SERVICE (EOS) AND HAS HAD A CHARGE CIRCUIT TIMEOUT. 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 15933483 ↗
• InjuryNov 22, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE INTERROGATION REPORT SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED ANTI-TACHYC ARDIA PACING (ATP) FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF), AND ALSO TREATED WITH SHOCKS. IT WAS SUSPECTED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT), AND THERAPY WAS INITIALLY WITHHELD, HOWEVER, IT WAS SUSPECTED THAT THE VENTRICULAR FIBRILLATION (VF) WAS STILL SUPRA VENTRICULAR TACHYCARDIA (SVT) AND THERAPIES WERE 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 15847789 ↗
• MalfunctionJul 20, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED SUPERIOR VENA CAVA (SVC) WHEN THE RHYTHM WAS VENTRICULAR TACHYCARDIA (VT) DUE TO ONSET. 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 15064798 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO ENDOCARDITIS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO A BACTERIAL INFECTION. ANTIBIOTICS WERE ADMINISTERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Chills; Diarrhea; Endocarditis

  MAUDE report 14735509 ↗
• InjuryMay 20, 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 REMOVED DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 14457368 ↗
• InjuryMay 9, 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 REMOVED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14342749 ↗
• MalfunctionApr 29, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER COULD NOT HEAR THE ALERT TONES FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHEN DEMONSTRATING TONES TO THE PATIENT. 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 14251973 ↗
• InjuryApr 18, 2022Reset Problem; Reset Problem

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT DURING THE PATIENT'S INTERNALLY DELIVERED CARDIOVERSION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A POWER ON RESET (POR). 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 14136060 ↗
• InjuryMar 8, 2022Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIAL INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. THE DEVICE WAVELET WAS ATTEMPTING TO WITHHOLD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 13693442 ↗
• InjuryDec 22, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR), WHICH WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 13062003 ↗
• MalfunctionDec 7, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED SVT (SUPRA VENTRICULAR TACHYCARDIA) WHEN IT IS BELIEVED TO BE A REAL VT (VENTRICULAR TACHYCARDIA) EPISODE. 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 12954060 ↗
• InjuryNov 12, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF) AND SHOCKED THE PATIENT. IT WAS SUSPECTED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12804632 ↗
• InjuryNov 7, 2021Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS T-WAVE OVERSENSING (TWOS). THE PATIENT'S MEDICATION WAS ADJUSTED AND THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 12759697 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12593199 ↗
• InjurySep 28, 2021Adverse 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 VEGETATION ON A CARDIAC VALVE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12540488 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SUBACUTE BACTERIAL ENDOCARDITIS AND WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE IMPLANT ABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM REMAINS IMPLANTED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12354277 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12232804 ↗
• InjuryDec 30, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTING AN SUPRA VENTRICULAR TACHYCARDIA (SVT) ARRHYTHMIA AS A VENTRICULAR TACHYCARDIA (VT) EPISODE. THE DEVICE WAS REPROGRAMMED AND 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 11097644 ↗
• MalfunctionNov 17, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Low impedance; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Low impedance

  IT WAS REPORTED THAT A LEAD ALERT HAD TRIGGERED DUE TO A ZERO IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE PATIENT WAS HAVING A MEDICAL PROCEDURE AT THE TIME OF THE ISSUE. 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 10852666 ↗
• MalfunctionOct 20, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT HEARD TWO "SOLID" ALERT TONES COMING FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). REMOTE MONITORING TRANSMISSION INDICATED THAT NO ALERT CRITERIA HAD BEEN MET. IT WAS SUSPECTED THAT THE PATIENT HAD A MAGNET EXPOSURE. THEICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10707836 ↗
• InjurySep 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET. THE ICD WAS EXPLANTED AND THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD CAPPED. THE SYSTEM WILL NOT BE REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 10482948 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AND THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD HAVE BEEN EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10314736 ↗
• MalfunctionJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CALLER QUESTIONED WHY THE DEVICE "DID NOT WORK THIS TIME WHEN IT WORKED BEFORE". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10212567 ↗