Protecta™ CRT-D D334TRMRecalls & reported problems
Medtronic, Inc. · CRT D334TRM PROTECTA CRT-D US MR DF4 · Class 3 · Implant
All models of Protecta CRT-D (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Protecta CRT-D is an implanted cardiac resynchronization defibrillator. The 23 reports mostly describe the battery discharging earlier than expected; others mention loss of telemetry, reset mode, or device replacement. The reports include 18 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994714619), received between Jun 8, 2017 and Sep 23, 2020 — classified as 18 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (14 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
Device problems
- Premature Discharge of Battery14
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Battery Problem: High Impedance1
- Delayed Charge Time1
- Electrical /Electronic Property Problem1
- Failure to Charge1
- Failure to Interrogate1
Patient problems
- No Known Impact Or Consequence To Patient20
- Complaint, Ill-Defined1
- Dyspnea1
- Staphylococcus Aureus1
- Unspecified Infection1
- Weakness1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗MalfunctionDec 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY A PATIENT FAMILY MEMBER THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS "NOT WORKING" AND TH E PATIENT HAD "EPISODES." THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Complaint, Ill-Defined
MAUDE report 8162069 ↗InjuryOct 24, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS "DEFECTIVE" AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8001856 ↗MalfunctionJun 19, 2018Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A TEN MONTH OLD EPISODE OF ATRIAL FIBRILLATION (AF) DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) APPEARED TO BE ELECTROMAGNETIC INTERFERENCE NOISE. THE DEVICE CURRENTLY APPEARED TO BE OPERATING AS PROGRAMMED AND 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 7614830 ↗InjuryJun 6, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS 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 7573052 ↗InjuryMay 3, 2018Premature 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 7484129 ↗InjuryApr 24, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS INCREASED AND ELEVATED THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE HAD REACHED BATTERY DEPLETION EARLY. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT IS ENROLLED IN THE POST APPROVAL NETWORK (PAN) CARDIAC AND VASCULAR GROUP (CVG) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7454451 ↗MalfunctionApr 10, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE HAD SHORT BATTERY LONGEVITY. 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 7417921 ↗InjuryFeb 8, 2018Premature 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 7255582 ↗InjuryFeb 8, 2018Premature 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 7255541 ↗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 7094164 ↗MalfunctionDec 7, 2017Battery Problem: High Impedance; Battery Problem: High Impedance
THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPLACED DUE TO REACHING NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7092431 ↗InjuryOct 6, 2017Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE CHANGEOUT PROCEDURE FOR THE DEVICE, DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI), THE RIGHT VENTRICULAR LEAD COULD NOT BE REMOVED FROM THE HEADER. A BONE SAW WAS USED TO CUT AWAY THE HEADER TO EXPOSE THE TIP OF THE LEAD. THE LEAD COULD THEN BE PUSHED OUT WITHOUT ANY DAMAGE. THE LEAD WAS TESTED WITH THE NEW DEVICE WITH NO ABNORMALITY. 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 6921238 ↗InjuryOct 6, 2017Premature 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 6919756 ↗InjuryAug 9, 2017Premature 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 6783190 ↗InjuryAug 9, 2017Delayed Charge Time; Delayed Charge Time
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED END OF SERVICE (EOS) DUE TO LONG CHARGE TIME. 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 6782517 ↗InjuryAug 9, 2017Premature 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 6782112 ↗InjuryAug 9, 2017Premature Discharge of Battery; Electrical /Electronic Property Problem; Premature Discharge of Battery; Electrical /Electronic Property Problem
IT WAS REPORTED THAT PATIENT¿S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A CHARGE CIRCUIT INACTIVE ALERT AND THE DEVICE INDICATED END OF SERVICE (EOS) 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 6779761 ↗MalfunctionAug 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD MIGRATED LATERALLY. THE POCKET WAS REVISED AND MOVED TO A MORE MEDIAL LOCATION AT THE NEXT GENERATOR CHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6779568 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS 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 6625779 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS 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 6625320 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page