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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRUG ELUTING STENT PCI; CORONARY DRUG - ELUTING STENT

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DRUG ELUTING STENT PCI; CORONARY DRUG - ELUTING STENT Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Cardiac Arrest (1762)
Event Date 05/30/2018
Event Type  Injury  
Event Description
Had a heart attack, they put in a stent called drug eluting stent then had another put in on (b)(6) 2018 the last one was (b)(6) 2018 that led to open heart and icd.Fda safety report id# (b)(4).
 
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Brand Name
DRUG ELUTING STENT PCI
Type of Device
CORONARY DRUG - ELUTING STENT
MDR Report Key8555749
MDR Text Key143450937
Report NumberMW5086217
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/23/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/25/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
INSERTION OF AV SEQUENTIAL ICD MODEL MEDTRONIC DDMB1D4, SERIAL #(B)(4)
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age54 YR
Patient Weight76
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