Protecta™ CRT-D D334TRG (UDI 00613994677853)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00613994677853), received between Feb 9, 2017 and Jul 23, 2024 — classified as 31 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (21 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED WITH EITHER OF TWO TABLET DEVICES. THE CRT-D 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 19807660 ↗
• MalfunctionSep 23, 2021Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), TWO YEARS PAST THE RECOMMENDED REPLACEMENT TIME (RRT), EXHIBITED A CHARGE CIRCUIT TIMEOUT AND AN INACTIVE CHARGE CIRCUIT. 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 12517929 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT'S OUTSIDE SKIN STARTED GETTING RED AND THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD BEEN EXPLANTED DUE TO A SEVERE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11588777 ↗
• InjuryNov 4, 2020Device Alarm System; Failure to Interrogate; Protective Measures Problem; Device Alarm System; Failure to Interrogate; Protective Measures Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED WITH A PROGRAMMER. IT WAS NOTED THAT THE PATIENT HEARD THE DEVICE ALERTING BACK IN (B)(6). IT WAS ALSO NOTED THAT A MAGNET WAS PLACED OVER THE DEVICE TO DETERMINE IF A TONE OCCUR AND A TONE DID NOT OCCUR. FOLLOW UP YIELDED NO INFORMATION. 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; No Consequences Or Impact To Patient

  MAUDE report 10787078 ↗
• MalfunctionMay 19, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT VENTRICULAR OVERSENSING AND NOISE WERE OBSERVED DURING A SURGICAL PROCEDURE. IT WAS SUSPECTED THAT THIS WAS DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITING ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING DURING THE PROCEDURE. THE CRT-D 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 10071095 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED. IT WAS FURTHER REPORTED THAT THERE WAS VEGETATION ON THE LEADS. THE DEVICE AND LEADS WERE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9986886 ↗
• MalfunctionSep 26, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT¿S SPOUSE CALLED TO REPORT THEY WERE AT THE ARRHYTHMIA CENTER FOR A DEVICE CHECK AND WERE TOLD THERE WAS A "POSSIBLE LOOSE WIRE CONNECTION AT THE TOP OF THE PACEMAKER." THE SPOUSE SAID THEY WERE NOT PLANNING TO DO ANYTHING BUT MONITOR IT FOR NOW. SPOUSE SAID THEY THINK MAYBE IT WAS FROM A "BYPASS SURGERY 6 MONTHS AGO". FOLLOW UP WAS CONDUCTED AND NO FURTHER INFORMATION COULD BE PROVIDED. 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 9126047 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION. THE PATIENT REPORTEDLY RECEIVED A NEW CRT-D AND LEFT VENTRICULAR (LV) LEAD THE SAME DAY WITH ADDITIONAL SYSTEM COMPONENTS FOLLOWING THE NEXT DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8523902 ↗
• InjuryApr 1, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INDICATED ELECTIVE REPLACEMENT (ERI) IN LESS THAN FIVE YEARS AND THE PHYSICIAN STATED THE DEVICE SHOULD HAVE LASTED LONGER. 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 8470817 ↗
• InjuryFeb 12, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 8333306 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED AN INFECTION. THE LEFT SIDED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8190925 ↗
• InjuryOct 19, 2018Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT TWO ROUNDS OF VENTRICULAR ANTI-TACHYCARDIA PACING WERE DELIVERED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR AN ATRIAL ARRHYTHMIA FOLLOWED BY DELIVERY OF A HIGH VOLTAGE DEFIBRILLATION THERAPY. THERE WAS A SUBSEQUENT CHANGE IN VENTRICULAR MORPHOLOGY WITH RAPID VENTRICULAR RATES AND ANOTHER HIGH VOLTAGE THERAPY WAS DELIVERED. THE DEVICE WAS EXPLANTED AND REPLACED SHORTLY THEREAFTER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 7985906 ↗
• InjuryAug 17, 2018Adverse 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 SEPSIS IN THE SETTING OF CANDIDA AND ENTEROBACTER BACTEREMIA. IT WAS THOUGHT THAT THE INFECTION WAS SECONDARY TO A CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION FROM THE PATIENT'S DIALYSIS CATHETER, BUT THE CANDIDA PERSISTED AFTER SWITCHING LINES. IT WAS DECIDED TO EXPLANT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. DURING THE EXPLANT PROCEDURE, THE HELIX ON THE PATIENT'S RIGHT ATRIAL (RA) LEAD AND A PREVIOUSLY CAPPED RIGHT VENTRICULAR (RV) LEAD WERE UNABLE TO BE RETRACTED. THE SYSTEM WAS EVENTUALLY EXPLANTED AND A TEMPORARY PACING LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7794912 ↗
• InjuryJul 9, 2018Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE HAD REACHED BATTERY DEPLETION PREMATURELY. 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 7670470 ↗
• InjuryMay 29, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. 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 7549679 ↗
• MalfunctionApr 10, 2018Over-Sensing; Invalid Sensing; Over-Sensing; Invalid Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FALSELY DETECTED A HIGH RATE NON-SUSTAINED EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE. 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 7418761 ↗
• InjuryApr 10, 2018Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND RECEIVED AN INAPPROPRIATE SHOCK FOR VENTRICULAR TACHYCARDIA AFTER ANTI-TACHYCARDIA PACING. REPROGRAMMING WAS DONE AND 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 7418459 ↗
• InjuryApr 10, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WAS EVALUATED IN CLINIC AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD REACHED PREMATURE ELECTIVE REPLACEMENT INDICATOR (ERI). THE LEFT VENTRICULAR (LV) LEAD ALSO SHOWED A HIGH PACING THRESHOLD, ALONG WITH INCONSISTENT CAPTURE. THE LV OUTPUT WAS INCREASED AND THE DEVICE WAS LATER 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 7415089 ↗
• InjuryFeb 8, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR DUE TO POSSIBLE PREMATURE BATTERY DEPLETION. 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 7257988 ↗
• InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. 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 7094462 ↗
• InjuryDec 7, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT A REMOTE TRANSMISSION NOTED ATRIAL UNDERSENSING ON CURRENT AND STORED ELECTROGRAMS. THERE WAS POSSIBLE UNDER DETECTION OF ATRIAL ARRHYTHMIA DUE TO LOW P-WAVE MEASUREMENT. THERE WAS ALSO A POSSIBLE INAPPROPRIATE SHOCK FOR RAPID VENTRICULAR RESPONSE DUE TO ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 7094401 ↗
• MalfunctionDec 7, 2017Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT DURING A DEVICE INTERROGATION, IT WAS NOTED THAT THERE WAS NOISE ON THE CAN-TO-RIGHT VENTRICULAR COIL CHANNEL ALONG WITH NOISE ON THE COMPETITOR ATRIAL LEAD. IT WAS ALSO NOTED THAT THE DEVICE WAS MODE SWITCHING DUE TO THE ATRIAL LEAD NOISE. THE PATIENT WAS UNAWARE OF ANY KNOW CAUSE FOR THE NOISE AS THE PATIENT WORKED ON COMPUTERS AND DID NOT OPERATE ANY HEAVY MACHINERY. 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 7094079 ↗
• InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. 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 7092074 ↗
• InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-D 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 7091047 ↗
• InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-D 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 7090958 ↗