Protecta™ XT DR D314DRG (UDI 00613994678188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994678188), received between Jun 8, 2017 and May 5, 2021 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS AT END OF SERVICE (EOS) AND A CHARGE CIRCUIT TIMEOUT ALERT OCCURRED. THE DEVICE WAS REPROGRAMMED 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 11778311 ↗
• InjuryMar 5, 2020Failure to Charge; Charging Problem; Failure to Charge; Charging Problem

  IT WAS REPORTED THAT THE DEVICE WAS AT RECOMMENDED REPLACEMENT TIME (RRT) AND THE PATIENT ELECTED NOT TO REPLACE THE DEVICE AT THAT TIME. THE DEVICE THEN ALERTED FOR CHARGE CIRCUIT TIMEOUT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEENREPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9792468 ↗
• MalfunctionAug 19, 2019Device Alarm System; Device Alarm System

  IT WAS FURTHER REPORTING THAT THE ICD WAS ALERTING DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS NOTED THAT THE ALERT SEEMED TO BE WORKING APPROPRIATELY AS PROGRAMMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906948 ↗
• MalfunctionFeb 7, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT DUE TO NORMAL BATTERY DEPLETION, THE PHYSICIAN NOTED HOW EASY THE ATRIAL LEAD CAME OUT OF THE DEVICE HEADER. THE SAME THING OCCURRED WITH THE DEFIBRILLATION LEAD PINS. THE PHYSICIAN DID NOT LOOSEN THE SETSCREWS AT ALL. HISTORICAL DATA WERE REVIEWED, WITH NO SETSCREW WARNINGS NOTED AND CONSISTENT IMPEDANCE VALUES. 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 8315871 ↗
• InjuryAug 24, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT HAD EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). 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 7812897 ↗
• InjuryApr 25, 2018Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT WHILE THE PATIENT WAS EXERCISING THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ENCOUNTERED A DETECTION ISSUE AND T-WAVE OVERSENSING (TWOS) PROBLEM. THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO T-WAVE OVERSENSING (TWOS) WHICH LEAD TO THE PATIENT RECEIVING INAPPROPRIATE THERAPY. ADDITIONALLY, IT WAS NOTED THAT THERE WAS ELECTROMAGNETIC INTERFERENCE (EMI) ON THE RIGHT ATRIAL (RA) LEAD EGM OF ONE OF THE RECORDED EPISODES. AS THE PATIENT WAS EXERCISING/SWIMMING DURING THIS EVENT, IT IS THOUGHT AN IMPROPERLY GROUNDED POOL MAY HAVE CAUSED/CONTRIBUTED TO THE EMI. REPROGRAMMING WAS COMPLETED AND THE DEVICE AND LEADS 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 7462062 ↗
• InjuryApr 10, 2018Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD FOR OVERSENSING WITH EPISODES OF AN INAPPROPRIATE SHOCK, HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). A FOLLOW UP WITH THE PATIENT¿S HEALTHCARE PROVIDER YIELDED THAT THE PATIENT UNDERWENT SURGERY WITH ELECTROCAUTERY AND THE PHYSICIAN DID NOT APPLY A MAGNET OVER THE ICD. THE ICD DETECTED THE ELECTROCAUTERY NOISE AND DELIVERED INAPPROPRIATE SHOCK THERAPY TO THE PATIENT. THE ICD WAS INTERROGATED TO CLEAR THE ALERT. 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 7413751 ↗
• InjuryApr 10, 2018Battery Problem; Data Problem; Battery Problem; Data Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH THRESHOLD. THE PHYSICIAN FELT THAT CAPTURE MANAGEMENT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE RECORDED THE THRESHOLD HIGH THAN NORMAL. THE LEAD WAS REPROGRAMMED. IT WAS ADDITIONALLY REPORTED THE DEVICE TRIGGERED AN ALERT FOR RECOMMENDED REPLACEMENT TIME (RRT) A FEW DAYS LATER. 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 7411656 ↗
• InjuryFeb 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S DEVICE ONLY LASTED SEVEN YEARS. 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 7255632 ↗
• InjuryJun 8, 2017Pacing Problem; Device-Device Incompatibility; Pacing Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT NEEDED PULMONARY TREATMENT USING ANOTHER MANUFACTURING COMPANY "VEST" THAT USES PNEUMATIC AIR PRESSURE TO CLEAR THE LUNGS. WHILE WEARING THE VEST, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RATE RESPONSE FEATURE WAS PACING AT THE UPPER SENSOR RATE. THE RATE RESPONSE WAS TURNED OFF DURING THE TREATMENT WITH THE VEST AS THIS RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6625621 ↗