Protecta CRT-DRecalls & reported problems across all models

We found 3 models of Protecta CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Jul 23, 2024 — classified as 51 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Protecta CRT-D problems

Protecta CRT-D models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Protecta™ CRT-D D334TRG

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  39 reports
• Protecta™ CRT-D D334TRM

  Implantable cardioverter defibrillator (non-CRT)
  23 reports
• Protecta™ CRT-D D334TRG

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 reports

Recent Protecta CRT-D adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 23, 2020Premature Discharge of Battery; Premature Discharge of Battery

  THE DEVICE WAS LATER CONFIRMED TO HAVE BEEN EXPLANTED AS PLANNED.

  Patient problems: Dyspnea; Weakness

  MAUDE report 10576173 ↗
• 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 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 9950467 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD (B)(6) FROM A SORE ON THEIR FOOT THAT SETTLED ON THE LEADS.

  Patient problems: Staphylococcus Aureus; Unspecified Infection

  MAUDE report 9766000 ↗
• 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 16, 2019Failure to Charge; Failure to Interrogate; Inappropriate or Unexpected Reset; Failure to Charge; Failure to Interrogate; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP AND AT A DEVICE CHECK IT WAS NOTED THAT THE DEVICE WAS IN POWER ON RESET MODE. THE DEVICE ALSO LOST TELEMETRY DURING INTERROGATION. IT COULD NOT BE CONFIRMED THAT THE DEVICE WAS AT END OF SERVICE (EOS). THE CLINICIAN ALSO NOTED THAT THERE WAS ALSO A CHARGE CIRCUIT TIMEOUT AT SOME POINT. 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 8518928 ↗
• 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 ↗

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