CapSureFix Novus Lead MRI SureScan

Description of Event or Problem

It was reported that the Right Ventricular (RV) lead exhibited oversensing during non-physiologic intervals. A Lead Integrity Alert (LIA) was triggered due to Sensing Integrity Counter (SIC) and pacing impedance variation. It was also noted that an alert was triggered due to high Out of Range (OOR) pacing impedance. The RV lead remains in use. It was further reported that the RV lead exhibited a spike in RV pacing impedance. A low voltage lead fracture was suspected. The RV lead was explanted. It was further reported that the patient experienced cardiac tamponade requiring intervention after the RV lead and Right Atrial (RA) lead were extracted. No further patient complications have been reported as a result of this event.

Additional Manufacturer Narrative

Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.