CapSure Sense MRI™ SureScan™ 407452 (UDI 00643169448940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169448940), received between Feb 8, 2018 and Jan 2, 2026 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (8 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD COULD NOT BE REPROGRAMMED DUE TO LOSS OF CAPTURE. THE RV LEAD 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 23942648 ↗
• MalfunctionJul 24, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM) TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING FOR A SINGLE BEAT ON STORED EGM. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587938 ↗
• InjuryOct 13, 2022Adverse 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 IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. ANTIBIOTICS WERE ADMINISTERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15593817 ↗
• MalfunctionSep 29, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-CAPTURE. THE RV LEAD 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 15508808 ↗
• MalfunctionAug 25, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONFUSION AND FATIGUE. THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED A GRADUAL INCREASE IN THRESHOLD. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Confusion/ Disorientation; Fatigue

  MAUDE report 15291894 ↗
• MalfunctionJul 25, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING DURING ARRHYTHMIAS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 15093950 ↗
• MalfunctionFeb 17, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 13548793 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE IPG SYSTEM WAS SENT FOR ANALYSIS OF BACTERIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12542600 ↗
• MalfunctionSep 16, 2021Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT V-V INTERVALS AND INHIBITING PACING. THE RV LEAD 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 12480206 ↗
• MalfunctionJun 10, 2021Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT NO PERFORMANCE ISSUES WERE NOTED WITH THE RV LEAD. THE PATIENT WAS EXPERIENCING AN ISCHEMIA WORK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11973407 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10244432 ↗
• InjuryJul 3, 2020Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS WHICH LED TO IMPLANTABLE PULSE GENERATOR (IPG) BATTERY DRAIN. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED AND DROPPED. THE RV LEAD, RA LEAD AND IPG WERE 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 10229538 ↗
• InjuryApr 6, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED PAIN AND PERMANENT PHYSICAL INJURY AS A RESULT OF THEIR IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE PATIENT REPORTED THEY WERE INCORRECTLY DIAGNOSED AND IMPLANTED WITH AN IPG SYSTEM WHICH WAS NOT NEEDED AND WHICH LED TO THEIR COMPLICATIONS. THE IPG SYSTEM WAS DEACTIVATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9928811 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. THE PATIENT RECEIVED A NEW IPG SYSTEM APPROXIMATELY ONE WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9081777 ↗
• MalfunctionJun 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE DOCTOR STATED THAT 'THOSE LEADS BREAK ALL THE TIME'. THE LEADS REMAIN 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 8706711 ↗
• InjuryMay 16, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WAS NO CAPTURE AND NO SENSING OBSERVED ON THE RIGHT ATRIAL (RA) LEAD, AND DISLODGEMENT WAS SUSPECTED. DURING THE PROCEDURE TO REPLACE THE RA LEAD, IT WAS NOTED THAT BOTH THE RA LEAD AND RIGHT VENTRICULAR (RV) LEAD HAD BEEN PULLED BACK SIGNIFICANTLY. THE RV LEAD WAS PULLED BACK FURTHER DURING THE PROCEDURE AND WAS REPOSITIONED AS A RESULT. THE RA LEAD 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 8616496 ↗
• MalfunctionApr 23, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH NUMBER OF SENSING INTEGRITY COUNTER (SIC) OVERSENSING EPISODES AND VENTRICULAR HIGH RATE EVENTS DUE TO NOISE. IT WAS NOTED THAT THE R WAVE WAS LOW. THE RV LEAD 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 8539462 ↗
• MalfunctionFeb 14, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ABDOMINAL PAIN. OVERSENSING AND NOISE WERE NOTED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. THE NURSE PRACTITIONER NOTED THE OVERSENSING WAS LIKELY DUE TO AN OPERATION ON THE SAME DATE. THE RA AND RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abdominal Pain

  MAUDE report 8340452 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. AN INTERROGATION REVEALED THAT THE THRESHOLDS APPEAR TO HAVE INCREASED IMMEDIATELY FOLLOWING IMPLANT. FLUOROSCOPY REVEALED THE LEAD WAS NO LONGER IN THE DESIRED LOCATION AND APPEARED TO HAVE PERFORATED INTO THE PERICARDIAL SPACE. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 8190608 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NERVE AND DIAPHRAGMATIC STIMULATION FROM THEIR RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 7720774 ↗
• InjuryJun 18, 2018Device Dislodged or Dislocated; Positioning Problem; High Capture Threshold; Unstable Capture Threshold; Device Dislodged or Dislocated; Positioning Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. THERE WAS PLACEMENT DIFFICULTY WITH THE LEAD NOT STAYING IN PLACE DURING REPOSITIONING. HIGH AND UNSTABLE THRESHOLD WAS ALSO OBSERVED. THE LEAD 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 7612111 ↗
• InjuryJun 15, 2018Intermittent Capture; Capturing Problem; Device Dislodged or Dislocated; High Capture Threshold; Intermittent Capture; Capturing Problem; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT A FEW WEEKS POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING TO HIGH THRESHOLDS. THERE WAS INTERMITTENT CAPTURE AT MAXIMUM OUTPUT IN BOTH UNIPOLAR AND BIPOLAR PACING. REVIEW OF A FLUOROSCOPY COULD NOT CONFIRM IF THE LEAD HAD MOVED SINCE THERE WAS NO PREVIOUS X-RAY, HOWEVER A DISLODGEMENT WAS SUSPECTED. THE PHYSICIAN CHOSE TO REMOVE THE LEAD AND REPLACE IT WITH AN ACTIVE FIXATION LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7607309 ↗
• InjuryJun 13, 2018Pacing Problem; Under-Sensing; Device Dislodged or Dislocated; High Capture Threshold; Pacing Problem; Under-Sensing; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT HAD MULTIPLE FIVE SECOND PAUSES. EVALUATION REVEALED AN INCREASE IN RV LEAD THRESHOLD. AN X-RAY CONFIRMED THAT THE RV LEAD HAD DISLODGED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bruise/Contusion; No Known Impact Or Consequence To Patient; Non specific EKG/ECG Changes; Syncope

  MAUDE report 7598815 ↗
• InjuryMay 29, 2018High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS FURTHER REPORTED THAT PROGRAMMING CHANGES WERE MADE TO ADJUST THE OUTPUT AND TURN OFF ADAPTIVE CAPTURE.

  Patient problems: No Code Available

  MAUDE report 7551642 ↗
• InjuryApr 25, 2018Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FOUND VIA X-RAY THAT THE LEAD HAD PULLED BACK AND DISLODGED. IT WAS ALSO NOTED THAT THE PATIENT WAS NOT GIVEN AN ARM IMMOBILIZER AS INSTRUCTED POST SURGERY. THE LEAD WAS REPOSITIONED 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 7461424 ↗