Evera MRI™ S DR SureScan™ DDMC3D1 (UDI 00643169837744)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00643169837744), received between Apr 25, 2018 and Feb 18, 2026 — classified as 2 deaths, 53 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1715-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) OTHER 1:1 DISCRIMINATOR WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). 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)

  MAUDE report 24381572 ↗
• InjuryJan 7, 2026Mechanical Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK AND PRESENTED TO THE ER (EMERGENCY ROOM). THE FIELD REP ATTEMPTED WITHOUT SUCCESS TO RECREATE OVERSENSING, BUT WAS OBSERVED BOTH BIPOLAR AND RVTIP TO RVCOIL ON THE RIGHT VENTRICULAR (RV) LEAD. THE ATRIAL LEAD AND RV LEAD ALSO SHOWED LOSS OF CAPTURE AND OVERSENSING. THE RV LEAD ALSO HAD HIGH THRESHOLD. IT WAS NOTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SIC (SENSING INTEGRITY COUNTER), A HIGH RV THRESHOLD WAS TRIGGERED, AND THERE WAS HIGH AND UNDEFINED PACING IMPEDANCE FOR THE RV LEAD. CURRENTLY DETECTIONS ARE PROGRAMMED OFF UNTIL THE PATIENT CAN SEE THEIR CARDIOLOGIST. IT WAS FURTHER REPORTED BY THE PATIENT THAT TWO TO THREE DAYS AFTER THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT, THE DEVICE SHOCKED THEM. THE PATIENT STATED THAT THEY CALLED AND STATED THAT "IT WAS NOT RIGHT" AND THAT THE CLINICIAN TURNED OFF THE LEAD. THE PATIENT CONTINUED, "WHEN THE LEAD WAS CONNECTED, IT WAS NOT DONE CORRECTLY. THEY REDID THE SURGERY TO RECONNECT IT." ADDITIONALLY, THE PATIENT STATED THAT THEY "WOKE UP WHEN THEY WERE SEWING" THEM BACK UP AND THEY "COULD F EEL EVERYTH

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23991349 ↗
• MalfunctionDec 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE "DEVICE IS DEAD" AND THAT THE COMPANY REPRESENTATIVE "COULD NOT GET A READING AT ALL". THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 23872281 ↗
• MalfunctionJul 17, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT THEY WENT IN AN UNGROUNDED POOL WHICH RESULTED IN ELECTROMAGNETIC INTERFERENCE (EMI) WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 22529957 ↗
• InjuryJun 11, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY WHICH APPEARED TO BE DUE TO OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SHORT V-V INTERVALS, AND A NOTICEABLE DIP IN THE RV COIL IMPEDANCE. IN ADDITION, THERE WAS ATRIAL LEAD NOISE OBSERVED. IT WAS FURTHER REPORTED THAT THE EVENT WAS DUE TO THE PATIENT HAVING AN EMERGENCY SURGERY WITH CAUTERY AND THE HOSPITAL DID NOT TURN OFF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTIONS OR USED A MAGNET. THE ICD, RV AND RIGHT ATRIAL (RA) LEADS 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 22190304 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 22133676 ↗
• InjuryMay 29, 2025Pacing 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) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED UNDERSENSING DURING TREATED VT OR VENTRICULAR FIBRILLATION (VF). THE DEVICE AND LEAD 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 22106051 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT PRESENTED TO PREPARATION AND RECOVERY FOR DEVICE EXPLANT. THE PATIENT WAS INITIALLY ADMITTED FOR A FOOT ULCER WITH POSITIVE BLOOD CULTURES, THAT HAD MOVED TO THE PATIENT'S LEFT ELBOW. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND SHOWED BACTERIAL GROWTH ON THE VALVES AND LEADS. THE DEVICE AND LEAD WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Ulcer

  MAUDE report 22014486 ↗
• MalfunctionApr 18, 2025Signal Artifact/Noise; Electromagnetic Interference; Protective Measures Problem; Signal Artifact/Noise; Electromagnetic Interference; Protective Measures Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI). EPISODES WITH NOISE AND OVERSENSING WERE OBSERVED AND A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED. 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 21867552 ↗
• InjuryMar 24, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN AN EPISODE OF VENTRICULAR TACHYCARDIA (VT). A REVIEW OF THE DEVICE DATA BY QUALIFIED PERSONNEL DETERMINED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INAPPROPRIATELY WITHHELD DUE TO THE DISCRIMINATOR FEATURE, THAT DETECTED THE EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21676855 ↗
• MalfunctionFeb 5, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT HEART RATES IN THE FORTIES AND ONGOING CHEST PAIN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Angina; Bradycardia

  MAUDE report 21313393 ↗
• MalfunctionJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT APPROXIMATELY TWO MONTHS AGO, A TABLE FELL FROM TEN FEET UP AND HIT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A COUPLE DAYS AFTER, THE PATIENT VISITED THEIR CLINIC DUE TO SWELLING AND FEELING UNCOMFORTABLE. A FEW DAYS FOLLOWING THEIR VISIT, THE CLINIC CALLED AND SAID THEY WERE IN ATRIAL FIBRILLATION (AF) FOR FOUR HOURS. THE PATIENT DOES NOT THINK THEIR DEVICE IS WORKING PROPERLY. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Swelling/ Edema

  MAUDE report 21217294 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A STREPTOCOCCUS INFECTION. THE SOURCE OF THE INFECTION WAS A URINARY TRACT INFECTION WITH FEVER AND BACTEREMIA. FIVE DAYS LATER, AN ECHOCARDIOGRAM INDICATED THAT THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD AND THE PATIENT EXPERIENCED ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Endocarditis; Fever

  MAUDE report 21023525 ↗
• DeathNov 5, 2024Electromagnetic Interference; Appropriate Device Problem Term/Code Not Available; Electromagnetic Interference; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ENCOUNTERED MAGNETIC INTERFERENCE AND TRIGGERED AN 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 20605885 ↗
• MalfunctionAug 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS "DEFECTIVE". IT WAS NOTED THAT THE TONING OCCURRED DUE TO THE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) BURDEN BEING MET. 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 19954605 ↗
• InjuryAug 7, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS DONE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19928820 ↗
• InjuryJul 17, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT CALLED STATING THAT THEY RECEIVED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK WHILE USING A NECK MASSAGER WITH TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS). IT WAS ALSO REPORTED THAT THE ICD STARTED BEEPING 5-7 MINUTES AFTER THE NECK MASSAGER WAS REMOVED AND MAGNET TONES WERE DISCUSSED. THE 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 19766413 ↗
• InjuryMay 22, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RA 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 19370031 ↗
• InjuryMay 7, 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) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHEN THE DEVICE DETECTED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN UNDERSENSED BEAT. THE ICD AND RV 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 19262339 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT¿S NEPHEW THAT THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AS IT WAS ¿CONTAMINATED¿, AND THE PATIENT HAD AN INFECTION. THE PATIENT TOOK MONTHS TO RECOVER, AND THE PATIENT¿S ARM WAS ¿VERY BLACK/BRUISED¿ FROM TAKING OUT THE ICD SYSTEM BUT THE PATIENT IS OKAY NOW. THE PATIENT HAD TO USE A TEMPORARY EXTERNAL PACEMAKER UNTIL THEY WERE HEALED AND THEN A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bruise/Contusion; Unspecified Infection

  MAUDE report 18586310 ↗
• InjuryJan 11, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED 12 SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE EPISODES THAT WERE DETECTED AS VENTRICULAR TACHYCARDIA (VT). IN ADDITION, THERE WAS OCCASIONAL UNDERSENSED BEATS DURING AT/AF AND VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) EPISODES NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND RA 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 18493211 ↗
• InjuryDec 4, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS FURTHER REPORTED THAT ONE MONTH PRIOR, THE PATIENT EXPERIENCED AN INAPPROPRIATE SHOCK FOR AF. THE PATIENT WAS HOSPITALIZED, WAS STARTED ON MEDICATION FOR AF MANAGEMENT, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED. THE PATIENT ALSO REPORTED FEELING GENERALIZED WEAKNESS AFTER THE HOSPITALIZATION. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy; Shock from Patient Lead(s)

  MAUDE report 18257612 ↗
• MalfunctionNov 17, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DETECTED SEVERAL EPISODES OF SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS SUSPECTED THAT THE SVT WAS TRULY VENTRICULAR TACHYCARDIA (VT), AND THERE WAS AN INAPPROPRIATE WITHHOLDING OF ANTI-TACHYCARDIA PACING THERAPIES. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18159759 ↗
• InjuryNov 7, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED EPISODES AND HIGH THRESHOLDS WHICH WERE CONSISTENT WITH HISTORICAL VALUES. THE ICD AND RA 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 18086153 ↗
• MalfunctionSep 26, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN BRADYCARDIA AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PACING THE PATIENT BELOW THE PROGRAMED LOWER RATE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. THE ICD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17817566 ↗