CapSureFix Novus MRI™ SureScan® 5076-85 (UDI 00643169550797)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169550797), received between Feb 9, 2017 and May 22, 2019 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO INFECTION. A NEW IPG AND RV LEAD WERE IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8630925 ↗
• InjuryApr 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OCCASIONAL COMPLETE HEART BLOCK. AN X-RAY VERIFIED BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS HAD DISLODGED. BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complete Heart Block

  MAUDE report 7417089 ↗
• InjuryOct 6, 2017Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEADS DISLODGED AND EXHIBITED HIGH THRESHOLDS. BOTH LEADS WERE 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 6922679 ↗
• DeathMar 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT PASSED AWAY AFTER AN OPERATION TO REMOVE AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM DUE TO INFECTION. A TEMPORARY LEAD WAS THEN PLACED. THE PATIENT PASSED AWAY IN THE OPERATING ROOM AFTER THE PROCEDURE WAS COMPLETED. THE CAUSE OF DEATH WAS UNABLE TO BE OBTAINED. A REVIEW OF THE PATIENT'S OBITUARY NOTES THE PATIENT PASSED AWAY DUE TO COMPLICATIONS FROM SURGERY. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED.

  Patient problems: Death

  MAUDE report 6404181 ↗
• InjuryFeb 9, 2017Failure to Sense; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; High Capture Threshold; Failure to Sense; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THEIR RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THE LEAD EXHIBITED HIGH THRESHOLDS AND NO SENSING WAS OBSERVED IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATION. A CHEST X-RAY REVEALED THAT THE LEAD HAD DISLODGED. THE LEAD WAS REPROGRAMMED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 6320291 ↗