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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING
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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RSINT30018UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Reaction (2414)
Date of Event 12/07/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The patient had a resolute integrity stent implanted.It was reported that the patient has be nauseous on and off since the procedure.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
RESOLUTE INTEGRITY RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6546933
Report Number9612164-2017-00564
Device Sequence Number16396609
Product Code NIQ
UDI-Device Identifier00643169037151
UDI-Public00643169037151
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P110013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/09/2018
Device Catalogue NumberRSINT30018UX
Device Lot Number0008093972
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/06/2017
Supplement Date Received by Manufacturer04/06/2017
Initial Report FDA Received Date05/05/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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