CapSure Sense MRI™ SureScan™ 407458 (UDI 00643169448957)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169448957), received between Apr 25, 2018 and Apr 8, 2026 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS REPROGRAMMED AND 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 24816204 ↗
• MalfunctionJul 31, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DURING VENTRICULAR TACHYCARDIA (VT) EPISODE ON STORED EL ECTROGRAMS (EGM), RESULTING IN FALSE TERMINATION OF EVENTS. 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 22673880 ↗
• MalfunctionJun 28, 2022Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONICALLY LOW R WAVES AND THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. BOTH PACING LEADS REMAIN 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 14842231 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET INFECTION. CULTURES WERE TAKEN AND (B)(6) WAS IDENTIFIED. ANTIBIOTICS WERE ADMINISTERED AND THE RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE PULSE GENERATOR (IPG) WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG).

  Patient problems: Unspecified Infection

  MAUDE report 9990297 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S PACEMAKER INCISION DID NOT HEAL PROPERLY RESULTING IN THE IMPLANTABLE PULSE GENERATOR (IPG) BEING EXPOSED. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IPG SYSTEM WAS EXPLANTED AND REPLACED SIX WEEKS AFTER IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9189871 ↗
• InjuryAug 12, 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 WITH SWELLING, WHITE DRAINAGE AND FEVER. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND A TEMPORARY LEAD WAS IMPLANTED WITH THE EXPLANTED IPG USED EXTERNALLY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND A NEW SYSTEM WILL BE IMPLANTED IN THE FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Swelling; Unspecified Infection

  MAUDE report 8883702 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE, CULTURES WERE TAKEN AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE ENTIRE PACING SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8756529 ↗
• InjuryApr 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED POST OPERATIVELY. THE RV LEAD WAS REVISED 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 8559823 ↗
• InjuryJan 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. 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 8228510 ↗
• InjuryNov 15, 2018Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Bradycardia

  MAUDE report 8074191 ↗
• MalfunctionOct 17, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES POST OPERATIVELY. FOLLOW UP FROM THE REP CONFIRMED THAT THE IMPEDANCES WERE ALL WITHIN LIMITS UPON A MANUAL INTERROGATION AND NO INTERVENTION WAS NEEDED ON THIS PATIENT. BOTH RA AND RV 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 7974119 ↗
• MalfunctionAug 9, 2018Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem

  THE PATIENT'S SON-IN-LAW REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH FOR TWO DAYS, OCCURRING WHEN THE PATIENT WAS WORKING IN THE YARD AND WHILE BENDING OVER. IT WAS ALSO NOTED THE PATIENT FELT JUMPY, POSSIBLY DUE TO PREMATURE VENTRICULAR CONTRACTIONS (PVCS). THE PATIENT BELIEVED THAT THE DEVICE WAS BROKEN OR THAT A LEAD WAS DISCONNECTED. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION. THE DEVICE AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 7767155 ↗
• InjuryJun 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND PULLED BACK FROM THE ORIGINAL APEX POSITION. A LEAD REVISION WAS COMPLETED AND 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 7610661 ↗
• InjuryApr 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, AS A TEMPORARY PACING WIRE WAS BEING REMOVED, THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND PATIENT EXPERIENCED TWENTY SECONDS OF ASYSTOLE. THE TEMPORARY WIRE WAS REINSERTED AND PACING RE-ESTABLISHED. SUBSEQUENTLY, THE RV LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 7461925 ↗