Protecta™ DR D334DRMRecalls & reported problems
Medtronic, Inc. · ICD D334DRM PROTECTA DR US MR DF4 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Protecta DR implantable cardioverter-defibrillator (CRT-D) is implanted under the skin to keep the heart rhythm steady. The 34 reports filed since December 2016 mostly describe the battery running down earlier than expected, along with charge circuit timeouts, shocks the patient felt, and pacing or sensing issues. Reports mention 1 death and 24 injuries. 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
- 34
- Deaths reported
- 1
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00613994714602), received between Dec 9, 2016 and Jun 8, 2023 — classified as 1 death, 24 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (17 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
Device problems
- Premature Discharge of Battery17
- Failure to Charge3
- Inappropriate/Inadequate Shock/Stimulation3
- Appropriate Device Problem Term/Code Not Available2
- Invalid Sensing2
- Mechanical Problem2
- Over-Sensing2
- Pacing Problem2
Patient problems
- No Known Impact Or Consequence To Patient23
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- Shock from Patient Lead(s)3
- Syncope2
- Death1
- No Code Available1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2023Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) AND A CHARGE CIRCUIT TIMEOUT OCCURRED SEVERAL YEARS AGO AND HAS NOW ALERTED FOR CHARGE CIRCUIT INACTIVE. THE PHYSICIAN AND PATIENT ELECTED TO LEAVE THE DEVICE IMPLANTED AND IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17086739 ↗MalfunctionFeb 2, 2023Failure to Charge; Failure to Charge
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PASSED END OF SERVICE (EOS) AND TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT ALL THERAPIES AND ALERTS WERE DEACTIVATED PRIOR TO CHARGE CIRCUIT TIMEOUT ALERT. 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 16282610 ↗InjuryFeb 2, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE REACHED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11266486 ↗InjuryOct 26, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10733388 ↗MalfunctionAug 6, 2020Pacing Problem; Pacing Problem
IT WAS REPORTED BY THE PATIENT THAT THEIR HEART RATE WAS LOWER THAN THAT OF THE PROGRAMMED LOWER RATE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 10373292 ↗InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT'S SPOUSE REPORTED THAT THE DEVICE "WENT BAD" AND IT HAD TO BE REMOVED. IT WAS INDICATED TO HAVE BEEN "DEFECTIVE." A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10369068 ↗MalfunctionApr 8, 2020Battery Problem; Battery Problem
THE PATIENT REPORTED HAVING "CONCERNS" ABOUT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY LONGEVITY. THE ICD 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 9934496 ↗InjuryFeb 26, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE SHOCKS FOR RVR (RAPID VENTRICULAR RESPONSE) FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). ADDITIONALLY, THERE WAS POSSIBLE INTERMITTENT ATRIAL UNDERSENSING NOTED ON THE CURRENT AND STORED EGM (ELECTROGRAMS) FOR THE ATRIAL LEAD. THE ICD WAS EXPLANTED AND REPLACED. THE ATRIAL LEAD 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 9759486 ↗InjuryJan 27, 2020Failure to Charge; Failure to Charge
THE PATIENT REPORTED HEARING BEEPING COMING FROM THE DEVICE. A DEVICE INTERROGATION INDICATED THAT THE DEVICE HAD A CHARGE CIRCUIT TIMEOUT. 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 9632914 ↗MalfunctionJan 22, 2020Missing Test Results; Missing Test Results
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRANSMISSION SHOWED THE "BATTERY VOLTAGE MEASUREMENT NOT AVAILABLE." THE ICD 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 9617861 ↗InjuryJan 14, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE PHYSICIAN NOTED THAT THERE WERE NO THERAPIES ACTIVATED DURING THE DEVICE'S LIFETIME, BUT THERE WAS 100% VENTRICULAR PACING. 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 9586057 ↗InjuryNov 11, 2019Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION. THE ICD EXPERIENCED UNEXPLAINED HIGHER THAN NORMAL CURRENT DRAIN DURING THE SIX MONTHS PRIOR TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE ICD 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 9305934 ↗MalfunctionAug 19, 2019Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE LCD 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 8907387 ↗MalfunctionJul 17, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A ROUTINE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT THE SET SCREW WAS VERY DIFFICULT TO GET OUT. THE WRENCH WOULD NOT ENGAGE THE SCREW. THE PHYSICIAN WAS ABLE TO FINALLY ENGAGE THE SET SCREW BUT IT CAME OUT OF THE DEVICE. THE DEVICE WAS REPLACED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8797806 ↗DeathDec 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT'S SPOUSE CALLED IN TO INQUIRE WHAT HAPPENS TO A PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ONCE THE PATIENT HAS PASSED AWAY. THE SPOUSE INDICATED THAT THE PATIENT WAS HAVING TROUBLE BREATHING AND THEY DID CARDIOPULMONARY RESUSCITATION (CPR) UNTIL THE EMERGENCY MEDICAL TECHNICIANS (EMT'S) ARRIVED AND CONTINUED THE CPR AND PROVIDED THE PATIENT MEDICATION AND "USED THE PADDLES" IN ORDER TO RESUSCITATE THE PATIENT. THE EFFORT WAS UNSUCCESSFUL, AND THE PATIENT HAD PASSED. THE SPOUSE ALLEGES THE ICD CONTRIBUTED TO PATIENT DEATH AND ASKED FOR THE DEVICE TO BE INTERROGATED IN AN EFFORT TO TELL THEM WHAT HAPPENED. THE CALLER WAS PROVIDED INFORMATION ON HOW TO RETURN THE DEVICE FOR ANALYSIS.
Patient problems: Death
MAUDE report 8170067 ↗InjuryNov 8, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE BATTERY OF THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED DUE TO THE PATIENT SENDING DAILY TRANSMISSIONS. THE ICD 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 8052310 ↗InjuryOct 24, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT AND PHYSICIAN WERE NOT PLEASED WITH THE UNEXPECTED SHORT LONGEVITY EXHIBITED BY THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE WAS EXTRACTED 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 8002210 ↗InjuryOct 1, 2018Mechanical Problem; Component Missing; Mechanical Problem; Component Missing
IT WAS REPORTED THAT THE PATIENT'S PHYSICIAN DID NOT FEEL THE SET SCREW RELEASE IN THE HEADER OF THEIR DEVICE. IT WAS NOTED THAT THE PHYSICIAN QUESTIONED WHETHER IT WAS PRESENT OR IN TACT. 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 7923116 ↗InjurySep 13, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7875452 ↗InjuryJul 24, 2018Failure to Interrogate; Output Problem; Failure to Interrogate
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO RECOMMENDED REPLACEMENT TIME (RRT). THE ICD SUBSEQUENTLY TESTED OUT OF SPECIFICATION AND WAS UNABLE TO BE INTERROGATED. IN ADDITION, IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE WARNING WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7715667 ↗InjuryJul 3, 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 7658508 ↗InjuryMay 1, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION AND THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR). 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 7477532 ↗InjuryApr 10, 2018Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPL ANTED 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 7417059 ↗InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION AND THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR). 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 7092710 ↗InjuryOct 6, 2017Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT AS THEY HAD A SYNCOPAL EPISODE WHILE SWIMMING IN A POOL AND RECEIVED A SHOCK FROM THEIR DEVICE. INTERROGATION OF THE DEVICE INDICATED THAT THE SHOCK WAS DELIVERED FOR WHAT APPEARS TO BE OVERSENSING/NOISE/EMI (ELECTROMAGNETIC INTERFERENCE). IT WAS NOTED THAT IT WAS POSSIBLE RELATED TO THE SWIMMING POOL/PUMP/LIGHTING. 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); Syncope
MAUDE report 6924639 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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