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

Catalog Number	RSINT22514W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	02/04/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated with the implant of a resolute integrity drug eluting stent.It was reported that the patient has the persistent feeling of a hole or burning in their heart.Feeling is resolved with medication.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6352198
• Report Number: 9612164-2017-00202
• Device Sequence Number: 13686446
• Product Code: NIQ
• UDI-Device Identifier: 00613994793232
• UDI-Public: 00613994793232
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2017

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 Catalogue Number: RSINT22514W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention