MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; RESOLUTE INTEGRITY

Model Number RSINT22522UX

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/07/2017

Event Type  Injury  

Event Description

No stent on fluoro.No stent found in body, bed, or floor.

• Brand Name: MEDTRONIC
• Type of Device: RESOLUTE INTEGRITY
• Manufacturer (Section D): MEDTRONIC; parkmore business park west; galway ; EI
• MDR Report Key: 6816514
• MDR Text Key: 83628085
• Report Number: MW5071771
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2019
• Device Model Number: RSINT22522UX
• Device Lot Number: 0008469805
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72