MAUDE Adverse Event Report: ST JUDE MEDICAL MASTER SERIES MECHANICAL HEART VALVE; HEART VALVE MECHANICAL

Model Number 27MJ-501

Device Problem Defective Component (2292)

Patient Problems Anemia (1706); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Regurgitation (2259)

Event Type  Injury  

Event Description

Reporter alleges her heart valve has been malfunctioning for about 2 years now, causing regurgitation and gastro-intestinal bleeding.This has affected her activities of daily living and she is mostly bedridden.She alleges physician was unable to fix the problem and her kidneys are too weak for a revision surgery.She goes for regular transfusions due to anemia and iron deficiency.She alleges she suffered a stroke and is on heparin and has allergies to "lovenos".She has reported this to the mfr in the past.

• Brand Name: MASTER SERIES MECHANICAL HEART VALVE
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 8194395
• MDR Text Key: 131597485
• Report Number: MW5082536
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 27MJ-501
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 67