MAUDE Adverse Event Report: SYNCARDIA TOTAL ARTIFICAL HEART

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).

• Brand Name: TOTAL ARTIFICAL HEART
• Type of Device: TOTAL ARTIFICAL HEART
• Manufacturer (Section D): SYNCARDIA
• MDR Report Key: 5811745
• MDR Text Key: 50298511
• Report Number: MW5063556
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 07/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 99