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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 UNK-CV-GWY-INT-DES
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Pain (1994); Reaction (2414); Blood Loss (2597)
Event Date 02/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient had a resolute integrity rx drug eluting stent implanted without any reported issue. Patient reported that they have experienced a number of negative symptoms ever since their resolute integrity stent was implanted: loss of eyesight, pain in wrist (site of catheter insertion), infection in their body that is affecting their bladder and kidneys, breathing problem (about 3 times per hour the patient gasps for air), cramping in muscles, skin is dried out, fatigue and headaches, nerve and joint pain, swollen ankles, and they can taste aluminium or copper in their mouth. They said that 4 hours after the stent was implanted they were hospitalised due to haemorrhaging. Patient was hospitalized for 9 days after this and passed two blood clots. Patient noted that they has been hospitalised almost every month since the stent was implanted. Patient noted that they had other stainless steel stents implanted, but didn't have any side effects from those. Patient has an appointment to see their cardiologist.
 
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Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7994734
MDR Text Key124679216
Report Number9612164-2018-02880
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-INT-DES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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