CapSureFix Novus MRI™ SureScan® 5076-35 (UDI 00643169633735)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169633735), received between Aug 1, 2018 and Aug 12, 2024 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Decreased Sensitivity” (2 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.

• MalfunctionAug 12, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. 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 19959915 ↗
• InjuryFeb 17, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYNCOPAL EPISODE AND FELL TO THE GROUND. THE RIGHT ATRIAL (RA) LEAD EXHIBITED POSSIBLE OVERSENSING ON SEVERAL ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Syncope/Fainting

  MAUDE report 16395416 ↗
• InjuryMay 13, 2022Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT POST IMPLANT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POOR P-WAVE SENSING. THE RA LEAD WAS REVISED 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 14399526 ↗
• InjuryJul 9, 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 EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12141437 ↗
• MalfunctionAug 24, 2020High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD IMPEDANCE WARNING. 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; No Consequences Or Impact To Patient

  MAUDE report 10441773 ↗
• InjuryApr 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENTS PARENT THAT RIGHT ATRIAL (RA) LEAD EXHIBITED DISLODGEMENT AND "WAS TURNED OFF". 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 9909780 ↗
• InjuryMar 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. THE LEAD WAS REVISED AND REMAINS IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9887582 ↗
• MalfunctionMar 25, 2020Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DIMINISHED SENSING. 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 9878873 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM IMPLANT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND SENT TO THE LABORATORY FOR CULTURES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9630980 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DAY AFTER THE IMPLANT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH CHEST PAINS WITH RESPIRATIONS. A COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM WAS DONE WHICH REVEALED A MODERATE TO LARGE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS DONE AND THE LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Pericardial Effusion

  MAUDE report 9530533 ↗
• MalfunctionDec 23, 2019Low impedance; Positioning Problem; Low impedance; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW UNIPOLAR IMPEDANCE AND WAS SUSPECTED TO HAVE MOVED PER X-RAY. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 9510368 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POCKET EROSION. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED WITH A TEMPORARY IMPLANTABLE PULSE GENERATOR (IPG) AND PACING LEAD AS THE PATIENT IS DEPENDENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNRESPONSIVE FOR TWO DAYS POST SURGERY DUE TO ANESTHESIA COMPLICATIONS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 8392313 ↗
• InjuryFeb 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS FURTHER SUSPECTED THAT THE RIGHT ATRIAL (RA) LEAD CAUSED PERICARDIAL EFFUSION. FLUID WAS DRAINED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Pericardial Effusion

  MAUDE report 8371036 ↗
• InjuryNov 21, 2018Electrical /Electronic Property Problem; Positioning Problem; Electrical /Electronic Property Problem; Positioning Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE PHYSICIAN REPORTED LEAD PLACEMENT DIFFICULTY. 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 8095161 ↗
• MalfunctionAug 1, 2018Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD SHOWED UNDERSENSING. 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 7738746 ↗