MAUDE Adverse Event Report: MEDTRONIC MOND STYLET; STYLET, CATHETER

Device Problems Product Quality Problem (1506); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

Intraoperatively the stylet was tight going down the lumen of the right ventricular(rv) lead.The stylet will not be returned.It was thrown away.I can confirm that multiple stylets were tried and same result.Both medtronic and the st.Jude mond stylets.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5119389.

• Brand Name: MOND STYLET
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17325040
• MDR Text Key: 319118301
• Report Number: MW5119388
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2023
• Patient Sequence Number: 1