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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING
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MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RONYX40015UX
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Itching Sensation (1943); Reaction (2414)
Date of Event 05/31/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: no dhr review required; does not meet the requirements of (b)(4) for dhr review.Ag 24-jun-2019.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A resolute onyx rx coronary, drug eluting stent was implanted.It is reported that the patient is having itching all over their body which wakes them up at night.The patient is working with an allergist and trying different combinations of drugs.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
RESOLUTE ONYX RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key8767243
Report Number9612164-2019-02742
Device Sequence Number13934666
Product Code NIQ
UDI-Device Identifier00643169557161
UDI-Public00643169557161
Combination Product (Y/N)N
PMA/510(K) Number
P160043
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 07/09/2019
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 Date11/19/2019
Device Catalogue NumberRONYX40015UX
Device Lot Number0008884452
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/11/2019
Supplement Date Received by Manufacturer06/11/2019
Initial Report FDA Received Date07/08/2019
Supplement Report FDA Received Date07/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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