Evera™ S DR DDBC3D4 (UDI 00643169530294)Recalls & reported problems
Medtronic, Inc. · ICD-DR DDBC3D4 EVERA S US DF4 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169530294), received between Feb 9, 2017 and Sep 14, 2026 — classified as 7 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Feb 3, 2021Open, Classified
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Z-1305-2021 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Sensing Problem2
- Inappropriate/Inadequate Shock/Stimulation2
- Pacing Problem2
- Appropriate Device Problem Term/Code Not Available1
- Electrical /Electronic Property Problem1
- Failure to Interrogate1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
- Shock from Patient Lead(s)2
- Syncope/Fainting2
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Dyspnea1
- Fall1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Device Sensing Problem
It was reported by the patient that their Implantable Cardioverter Defibrillator (ICD) "went off during the night" and they "felt funny" and was "coming in and out of it". The patient also stated that they "fainted and fell" and remembered "coming back" and "gasping for air". The ICD remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Dyspnea; Fall; Shock from Patient Lead(s); Syncope/Fainting
MAUDE report 50757021 ↗InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23908361 ↗MalfunctionNov 6, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20624806 ↗InjuryAug 8, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED BY THE PATIENT THAT THEY HAD RECEIVED A SHOCK FROM THEIR IMPLANTED DEVICE, AND HAD PASSED OUT THE DAY PRIOR. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE REMOTE MONITOR DID NOW SHOW INFORMATION OF TRANSMISSION THAT WAS SENT OUT BY THE PATIENT. THE PATIENT WAS INFORMED THAT IT WOULD AUTOMATICALLY DOWNLOAD AND SENT TO THE CLINIC. THE PATIENT MANAGEMENT DATABASE CONFIRMED THAT THE REMOTE MONITOR DID NOT HAVE ANY SUCCESSFUL AUTOMATIC TRANSMISSIONS SINCE THE DATE OF THE CALL. THE PATIENT WAS REFERRED TO A DEVICE SPECIALIST. THE MONITOR REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Syncope/Fainting
MAUDE report 19942707 ↗MalfunctionMay 21, 2021Pacing Problem; Pacing Problem
THE PATIENT'S SPOUSE REPORTED THAT WHILE THE PATIENT WAS IN THE HOSPITAL, THE PATIENT WAS NOTED TO HAVE A HEART RATE THAT WAS LOWER THAT THE PROGRAMMED RATE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INDICATED TO NOT BE "FIRING." THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11864718 ↗InjuryApr 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS FURTHER REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROPHYLACTICALLY REPLACED DUE TO REQUIRING AN UPGRADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11708207 ↗MalfunctionDec 17, 2020Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED AFTER SEVERAL ATTEMPTS WITH MULTIPLE PROGRAMMERS. 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 11028610 ↗InjuryOct 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR A PACING IMPEDANCE READING OF ZERO. IN ADDITION, THE RV LEAD WAS EXHIBITING SENSING INTEGRITY COUNTER (SIC) THAT STARTED ABRUPTLY AND INCREASED DAILY. THE RV LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT THE PHYSICIAN THOUGHT THE IMPEDANCE AND SIC ISSUES COULD BE RELATED TO THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 7945095 ↗InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT PRESENTED TO THE URGENT CARE WITH A FEVER, AN INCREASE IN POCKET PAIN AND SWELLING. WOUND CULTURES AND BLOOD TESTS WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. IT WAS ALSO REPORTED THE PATIENT DEVELOPED AN INFECTION OF THE LEFT SIDE OF THE POCKET. THE PATIENT WAS TREATED WITH ORAL AND INTRAVENOUS ANTIBIOTICS AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM WAS REMOVED. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Fever; Pain; Staphylococcus Aureus; Swelling; Unspecified Infection
MAUDE report 7597562 ↗MalfunctionApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PREPARED FOR POTENTIAL IMPLANT, HOWEVER THERE WAS A GREY BAR FOR BATTERY LONGEVITY. THE DEVICE WAS RECHECKED SIX DAYS LATER AND THE GRAY BAR CONTINUED. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7417028 ↗InjuryOct 6, 2017Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM DUE TO SHOCKS RECEIVED FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THAT THERE WERE ELEVEN HIGH RATE NON SUSTAINED EPISODES, AND OVER ONE HUNDRED AND THIRTY ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES. AS WELL, THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW). FOLLOW UP WAS CONDUCTED TO NO AVAIL. THE DEVICE IS STILL IN USE. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 6920244 ↗MalfunctionAug 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) "LOOKED WEIRD; FELT LIKE IT HAD MOVED." FOLLOW UP WAS CONDUCTED TO NO AVAIL. THE DEVICE IS STILL 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 6781849 ↗MalfunctionFeb 9, 2017Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING A GENERATOR CHANGE WITH A COMPETITOR LEAD THE LEAD WOULD NOT SEAT PROPERLY IN THE DEVICE HEADER AND FRICTION WAS REPORTED. THE LEAD WAS REPORTED TO BE SEATED ONCE OR TWICE HOWEVER THE SET SCREW APPEARED TO PUSH THE LEAD BACK. THE DEVICE WAS NOT USED AND A DIFFERENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 6321075 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- 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