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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC CORONARY DRUG-ELUTING STENT RESOLUTE INTEGRITY

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MEDTRONIC MEDTRONIC CORONARY DRUG-ELUTING STENT RESOLUTE INTEGRITY Back to Search Results
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.
 
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Brand NameMEDTRONIC CORONARY DRUG-ELUTING STENT
Type of DeviceRESOLUTE INTEGRITY
Manufacturer (Section D)
MEDTRONIC
parkmore business park west
galway
EI
MDR Report Key6800093
MDR Text Key83036551
Report NumberMW5071603
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/25/2019
Device Model NumberRSINT22522UX
Device Lot Number0008469805
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/15/2017 Patient Sequence Number: 1
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