MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number	RSINT40022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a resolute integrity rx drug eluting stent developed reaction symptoms less than a year later.These included ulcerative colitis, pain swelling in joints, decreased energy levels.The patient also experienced eczema which was reported to be increasingly getting worse.The patient had a patch test revealing a nickel allergy.Patient has no previous stents implanted.Patient treated with medication.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6306686
• Report Number: 9612164-2017-00110
• Device Sequence Number: 13578416
• Product Code: NIQ
• UDI-Device Identifier: 00643169037229
• UDI-Public: 00643169037229
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2017

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 Date: 11/09/2014
• Device Catalogue Number: RSINT40022UX
• Device Lot Number: 0006740095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91