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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE HEART MEDICAL HEART VALVE REPLACEMENTS MASTERS SERIES MECHANICAL HEART V; HEART VALVE MECHANICAL

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ST JUDE HEART MEDICAL HEART VALVE REPLACEMENTS MASTERS SERIES MECHANICAL HEART V; HEART VALVE MECHANICAL Back to Search Results
Model Number 27MJ-5013
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Anemia (1706); Fatigue (1849); Hemorrhage/Bleeding (1888); Pulmonary Edema (2020); Regurgitation (2259)
Event Date 04/10/2009
Event Type  Injury  
Event Description
Lovenox injection to bridge warfarin therapy.(b)(6) 2009 through 2015, pt blood transfused every 10 days for gastrointestinal hemorrhage.Hemophilia, causing chronic kidney and liver disease, anemia, unusual tiredness, bronchial wall thickening, chronic heart disease, fluid retention, excessive fat in blood, high amount of potassium gastrointestinal hemorrhage 10 days after bridging lovenox for warfarin therapy; including over 100 transfusions, countless endoscopic exploratory treatments, with extended hospitalization for 2009 through 2015.St jude medical (b)(4).Mitral valve malfunction / regurgitation attempted repair and reused 2017, unsuccessful.Enlarged ventricle of heart to remove blood adequately causing pulmonary edema.
 
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Brand Name
ST JUDE HEART MEDICAL HEART VALVE REPLACEMENTS MASTERS SERIES MECHANICAL HEART V
Type of Device
HEART VALVE MECHANICAL
MDR Report Key8260608
MDR Text Key133832042
Report NumberMW5083209
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number27MJ-5013
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention;
Patient Age70 YR
Patient Weight67
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