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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA TOTAL ARTIFICAL HEART

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SYNCARDIA TOTAL ARTIFICAL HEART Back to Search Results
Device Problems Premature Discharge of Battery (1057); Mechanical Problem (1384); Low Battery (2584); Battery Problem (2885); Noise, Audible (3273)
Patient Problem Failure of Implant (1924)
Event Date 07/08/2016
Event Type  Injury  
Event Description
The latest issue was that on (b)(6) we had to do an emergency change of the syncardia freedom driver.The driver was (?) than 30 days old, started with a grinding noise and then non-stop sound of bird chirping.Call (b)(6) and was told to come in.They heard the noise, called syncardia and told to replace the device.My husband has been on the freedom driver for over 2 years.We have had ongoing issues with quality of the devices and batteries.We have experienced a number of freedom drivers that fail in less than the 90 day time frame and then moved to a 60 change out time to avoid failures.Unfortunately, while changing one device it started to red alarm within minutes of the change and had to be changed again before leaving the hospital clinic.We just experienced another device that my husband had less than 30 days, it started grinding and then started sounding like a bird chirping.It was on the verge of failing and did when we were at the clinic changing the device.We also had numerous issues with batteries not holding charges.We were travelling outside area, went to restaurants with charged batteries, when it was time to change batteries, put in charged batteries that all showed complete charge leaving hotel.Once put in freedom driver, machine red alarmed.Lucky had another set and changed out and then alarm stopped.Syncardia had to replace the batteries.The quality is very concerning as this is a life saving device.I understand there may be a random issue but we continue to see ongoing issues with the stability and quality of the devices.I would be happy to discuss further and believe you should be aware of the quality issues of the syncardia tah freedom driver.(b)(6).
 
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Brand Name
TOTAL ARTIFICAL HEART
Type of Device
TOTAL ARTIFICAL HEART
Manufacturer (Section D)
SYNCARDIA
MDR Report Key5811745
MDR Text Key50298511
Report NumberMW5063556
Device Sequence Number1
Product Code LOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 07/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/18/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight99
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