CapSure Sense MRI™ SureScan™ 457445 (UDI 00643169410954)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169410954), received between Apr 10, 2018 and Mar 27, 2024 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD TRIGGERED AN ALERT FOR HIGH ATRIAL THRESHOLDS. FOUR MONTHS LATER, THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED UNDERSENSING ON ONE BEAT ON THE CURRENT ELECTROGRAM (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 18986324 ↗
• MalfunctionMar 19, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING NOTED ON CURRENT ELECTROGRAMS (EGM). THE 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 18932959 ↗
• MalfunctionNov 7, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING/ATRIAL EVENTS FALLING IN BLANKING ON STORED ELECTROGRAMS (EGM), HOWEVER, THE DEVICE IS STAYING MODE SWITCHED. THE 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 18081993 ↗
• MalfunctionApr 4, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE RA 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 16673424 ↗
• MalfunctionOct 2, 2022Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN A RATE RESPONSIVE PACING. THE 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 15526137 ↗
• MalfunctionSep 7, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT INTERMITTENT ATRIAL UNDERSENSING BY THE RIGHT ATRIAL (RA) LEAD WAS SUSPECTED DURING RECORDED EPISODES. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH-RATE, NON-SUSTAINED (HRNS) EPISODES AND INCREASED SENSING INTEGRITY COUNTER (SIC). 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 15374196 ↗
• InjuryNov 11, 2021High impedance; Capturing Problem; Device Dislodged or Dislocated; High impedance; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE, AND A GRADUAL RISE IN THRESHOLDS. IT WAS FURTHER NOTED THAT UNDER FLUOROSCOPY THE RA LEAD HAD VERY LITTLE SLACK AND HAD MOST LIKELY PULLED BACK FROM ITS ORIGINAL POSITION. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800913 ↗
• MalfunctionNov 24, 2020Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED IMPEDANCE WARNING AND HIGH THRESHOLDS. THE RA 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 10895028 ↗
• InjurySep 5, 2019Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DAY AFTER THE IMPLANT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD DISLODGED DUE TO PATIENT ANATOMY, WITH A RISE IN THRESHOLDS. 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 8964232 ↗
• MalfunctionJul 22, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING AND NOISE. 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 8810867 ↗
• InjuryMay 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE DAY POST REPLACEMENT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD HAD NO CAPTURE. IT WAS NOTED THAT A CHEST X-RAY REVEALED THE RA LEAD DISLODGED. DURING LEAD REVISION, AFTER THE LEAD WAS REVISED THE PHYSICIAN WENT TO REATTACH THE LEAD INTO THE HEADER AND THE WRENCH WOULD NOT ENGAGE INTO THE SET SCREW. THE PHYSICIAN COULD NOT SCREW THE LEAD BACK INTO THE SET SCREW. THE DEVICE WAS EXPLANTED AND REPLACED, AND 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 8633662 ↗
• InjuryAug 8, 2018Failure to Capture; Under-Sensing; High Capture Threshold

  IT WAS LATER REPORTED THAT ATRIAL OUTPUT HAD BEEN INCREASED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7764090 ↗
• MalfunctionJul 5, 2018Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS OBSERVED WITH FUNCTIONAL UNDERSENSING WITH ATRIAL EVENTS FALLING INTO THE BLANKING AT TIMES. THE 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 7664604 ↗
• InjuryApr 30, 2018Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT FIVE DAYS POST IMPLANT, THE PATIENT EXPERIENCED DIZZINESS AND THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS, NO CAPTURE AND HAD DISLODGED. THE LEAD WAS REVISED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 7473779 ↗
• InjuryApr 10, 2018Failure to Capture; Device Sensing Problem; Device Dislodged or Dislocated; Failure to Capture; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE RA WAS NOT SENSING OR CAPTURING, AND X-RAY CONFIRMED THE LEAD HAD PULLED BACK. THE ATRIAL 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 7418802 ↗