Evera MRI™ S DR SureScan® DDMC3D4 (UDI 00643169929265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169929265), received between Feb 8, 2018 and Mar 5, 2026 — classified as 1 death, 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• DeathMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED WITH THE CAUSE OF DEATH NOTED AS COMPLICATIONS OF A CEREBRAL VASCULAR ACCIDENT AND GASTROINTESTINAL BLEEDING. THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24524499 ↗
• MalfunctionSep 21, 2024False Alarm; Signal Artifact/Noise; Electromagnetic Interference; False Alarm; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE THAT RESULTED IN NOISE ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD, AND CAUSED A LEAD INTEGRITY ALERT (LIA) TO TRIGGER. IT WAS NOTED THAT THE PATIENT HAD SAID THEY HAD HEARD ALERT TONES. 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 20275113 ↗
• InjurySep 16, 2024Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY. A POST ABLATION DEVICE CHECK NOTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). THERE WAS OVERSENSING NOTED ON BOTH VENTRICULAR AND ATRIAL CHANNELS WHICH WAS POSSIBLY DUE TO EXTERNAL FORCES DURING THE VENTRICULAR TACHYCARDIA (VT) ABLATION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 20226102 ↗
• InjuryMar 18, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR TACHYCARDIA (VT), PROVIDED ANTI-TACHYCARDIA PACING, AND SHOCKED THE PATIENT. IT WAS SUSPECTED THAT THE RHYTHM WAS SUPRA VENTRICULAR TACHYCARDIA (SVT), THEREFORE THE SHOCK/THERAPIES WAS INAPPROPATE. IT WAS ALSO NOTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND 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 18923188 ↗
• InjuryJun 7, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR DETECTING ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AS A VENTRICULAR FIBRILLATION (VF) EPISODE. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS INTERMITTENT UNDERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17083044 ↗
• MalfunctionDec 7, 2021Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD HAD OVERSENSING OF NOISE THAT WAS REPRODUCIBLE WITH POCKET MANIPULATION. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD T-WAVE OVERSENSING (TWOS) SEEN ON SEEN ON SENSING INTEGRITY COUNTER (SIC) EPISODES. UPON REVIEW OF ELECTROGRAMS, A PREMATURE VENTRICULAR CONTRACTIONS (PVC) OCCURRED COINCIDENTLY WITH THE TWOS RESULTING IN THE SHORT V-V INTERVALS. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING SEEN ON STORED ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EPISODES AND ON HIGH RATE NON-SUSTAINED (HR-NS) EPISODES. 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 12956930 ↗
• InjuryMar 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT CALLED AND SAID THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS DEFECTIVE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; No Known Impact Or Consequence To Patient

  MAUDE report 9795758 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9735063 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9629091 ↗
• MalfunctionOct 1, 2019Mechanical Problem; Mechanical Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALSO DISPLAYED LOW IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. DURING THE LEAD REVISION PROCEDURE THE PHYSICIAN WAS UNABLE TO ENGAGE THE SETSCREW ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HEADER. THE DEVICE WAS NOT REIMPLANTED AND AN ALTERNATE DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9140683 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF POCKED DISCOMFORT FOR ABOUT A MONTH AND THE POCKET BEGAN TO SWELL. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND CULTURES WERE POSITIVE FOR INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8856240 ↗
• MalfunctionMar 7, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) EXHIBITED GRAY BAR ON INTERROGATION, INDICATING LOW TELEMETRY VOLTAGE. THE ICDS WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8401777 ↗
• MalfunctionFeb 11, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED A GRAY BAR ON INTERROGATION, INDICATING LOW TELEMETRY BATTERY VOLTAGE. THE DEVICE WAS LEFT IN A WARM CLIMATE FOR A WEEK, RE-INTERROGATED, AND THE GRAY BAR PERSISTED. THE DEVICE WAS NOT USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8325093 ↗
• MalfunctionJan 30, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN THE DEVICE WAS CHECKED PRIOR TO ANY IMPLANT PROCEDURE, THE GRAY BAR WAS PRESENT. THE DEVICE WILL NOT BE IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8288941 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY FELT LIKE THEY WERE HAVING A BODY RUSH, LIKE A HEAD RUSH AND THEN COLD CHILLS. THE PATIENT WENT TO THE ER (EMERGENCY ROOM) AND AN ADJUSTMENT WAS MADE TO THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WAS TOLD THAT IT WAS ADJUSTED TOO SENSITIVE AND THAT IS WHY THEY CHANGED IT. THE PATIENT STATED THAT AFTER THE ADJUSTED THEIR SYMPTOMS GOT BETTER BUT NOW SOME SYMPTOMS WERE BACK. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chills

  MAUDE report 7980755 ↗
• MalfunctionSep 5, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT PROCEDURE THE WRENCH IDD NOT "CLICK" WITH THE SET SCREW. THE SET SCREW COULD NOT BE REMOVED. DEFIBRILLATION THRESHOLD TESTING WAS COMPLETED AS WELL AS VISUAL INSPECTION OF THE HEADER. DEVICE FUNCTION WAS NOTED AS NORMAL. THE DEVICE REMAINS IMPLANTED AND 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 7846121 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANT SITE WAS SWOLLEN. WHEN THE POCKET WAS OPENED UP TWO GAUZE SPONGES WERE FOUND WHICH HAD BEEN LEFT FROM THE ORIGINAL IMPLANT APPROXIMATELY 4 MONTHS PRIOR. A HEMATOMA WAS ALSO REPORTED. THE PATIENT WAS GIVEN ANTIBIOTICS AND CULTURES WERE TAKEN. THE ICD SYSTEM WAS EXPLANTED AND A TEMPORARY PACEMAKER WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Swelling; Unspecified Infection

  MAUDE report 7459619 ↗
• MalfunctionFeb 8, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PHYSICIAN COULD NOT GET THE SCREW TO TIGHTEN IN THE HEADER. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7257358 ↗