MAUDE Adverse Event Report: MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5076

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that this lead was difficult to place.The physician suspected that patient anatomy could be a factor.This lead remains in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CAPSUREFIX NOVUS MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488365
• MDR Text Key: 320680881
• Report Number: MW5121064
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Patient Sequence Number: 1